Traditional Chinese medicine composition for treating atopic dermatitis

Abstract

The invention belongs to the field of traditional Chinese medicines and particularly relates to a traditional Chinese medicine composition for treating skin diseases. The traditional Chinese medicine composition for treating skin diseases is further optimized on the basis of water-nourishing and heart-fire-clearing drink, takes kidney nourishing, heart-fire clearing, food retention removing and stagnation removing as a core treatment rule, has the advantages of less medicine flavor, good taste, quick effect, high safety and better curative effect, and provides a treatment scheme for patients with atopic dermatitis and heat accumulation in heart and spleen. The traditional Chinese medicine composition is prepared from coptis chinensis, radix rehmanniae, cape jasmine, hawthorn, medicated leaven, uncaria, purslane, rhizoma atractylodis, honeysuckle, Chinese herbaceous peony, folium isatidis, malt, cortex dictamni, raw oyster, scutellaria baicalensis, lophatherum gracile, fructus aurantii, semen raphani and betel nut.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating skin diseases. Background Technology

[0002] Atopic dermatitis (AD) is a common chronic inflammatory skin disease characterized by dry skin, significant itching, and eczematous lesions, severely impacting patients' quality of life. AD presents with different characteristics at different ages and can be divided into four stages: infancy, childhood, adolescence and adulthood, and old age. Infancy (birth to 2 years): Typically presents as erythema and scaling on both cheeks. The rash can extend to the scalp, neck, forehead, etc. Severe exudation and secondary changes due to scratching and friction may occur. Childhood (2 to 12 years): It can be a continuation of the previous stage or a direct onset of the disease. It often occurs in the elbow and popliteal fossa, flexor wrist, eyelids, and around the neck. It is usually a hard, lichenified plaque with scratch marks and crusts. Adolescent and adult (12 to 60 years): In adolescent patients, the rash often appears typically in the elbow and popliteal fossa, front and side of the neck, and around the eyes. Overall, the skin is noticeably dry, and lichenification and prurigo-like papules are common. Elderly (over 60 years): There are more elderly male patients. The rash is often more severe than in the previous stages, and may even spread throughout the body, resulting in erythroderma (Lv Ting, Wang Hongwei. Understanding and management of atopic dermatitis in the elderly [J]. Chinese Journal of Dermatology and Venereology, 2019, 33(08): 949-54). Damaged skin barrier leads to greater transepidermal water loss and transepidermal penetration of microorganisms and allergens, which may eventually trigger an inflammatory cascade (Baurecht H, Rühlemann MC, Rodríguez E, et al. Epidermal lipid composition, barrier integrity, and eczematous inflammation are associated with skin microbiome configuration[J]. Journal of Allergy and Clinical Immunology ,2018,141(5):1668-1676.e16.).

[0003] The severity of Alzheimer's disease (AD) lesions can be quantified using multiple scoring tools, primarily the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis Rating (SCORAD) scale, both of which are widely used in clinical diagnosis and clinical trials (Chopra R, Vakharia PP, Sacotte R, et al. Severity strata for Eczema Area and Severity Index (EASI), modified EASI, Scoring Atopic Dermatitis (SCORAD), objective SCORAD, Atopic Dermatitis Severity Index and body surface area in adolescents and adults with atopic dermatitis[J]. British Journal of Dermatology, 2017, 177(5):1316-1321.). The EASI score assesses the severity of redness, thickness, scratches, and lichenification of four body areas (head, trunk, arms, and legs), as well as the percentage of skin involved. Compared to the EASI score, the SCORAD score incorporates the physician's objective assessment of the extent and severity of eczema lesions. It is calculated based on the affected skin area, redness, oozing, crusting, lichenification, and dryness severity, assessing the severity of the head and neck, arms and legs, forequarters, back, and genitals (Charman CR, Venn AJ, Williams H, et al. Measuring Atopic Eczema Severity Visually: Which Variables Are Most Important to Patients?[J]. Archives of Dermatology, 2005, 141(9).). The score also includes two subjective assessments by the patient: one for sleep deprivation and the other for itching.

[0004] Atopic dermatitis is a chronic, relapsing disease requiring long-term treatment. Chinese guidelines recommend a stepwise treatment approach based on disease severity (Immunology Group of the Dermatology and Venereology Branch of the Chinese Medical Association, Collaborative Research Center for Atopic Dermatitis. Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis (2020 Edition) [J]. Chinese Journal of Dermatology, 2020, (02): 81-8.). Mild atopic dermatitis is mainly treated with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), and topical phosphodiesterase-4 (PDE-4) inhibitors. For moderate to severe atopic dermatitis that significantly impacts patient health, topical medications alone are often insufficient to control the condition, necessitating systemic treatment. Traditional systemic medications include cyclosporine, methotrexate, and azathioprine. In recent years, the clinical application of biologics and Janus inhibitors has provided more effective and relatively safe options for systemic treatment of moderate to severe AD patients. However, although there are many treatment options for AD, many traditional methods cannot achieve satisfactory efficacy or cannot be used for a long time due to safety reasons. Common adverse reactions of cyclosporine include renal dysfunction, headache, hypertension and hyperlipidemia; methotrexate has adverse reactions such as ulcerative stomatitis, leukopenia, hepatotoxicity and myelosuppression; azathioprine may cause hemoglobin, leukopenia and liver damage. Dupilumab has insufficient efficacy for some patients, while others lose response as the duration of treatment (possibly due to the formation of drug-neutralizing antibodies) (HENDRICKS AJ, LIO PA, SHI V Y. Management Recommendations for Dupilumab Partial and Non-durable Responders in Atopic Dermatitis [J]. American Journal of Clinical Dermatology, 2019, 20(4): 565-9.). Furthermore, its administration method is subcutaneous injection, which some patients refuse due to their unwillingness to undergo injection. Janus inhibitors are relatively expensive, have strict age restrictions, and long-term use carries risks of infection, cardiovascular disease, and tumors. Therefore, for AD patients, there is a need for an oral treatment method that offers good benefits and low risks.

[0005] Traditional Chinese medicine (TCM) has a long history of treating atopic dermatitis, but the term "atopic dermatitis" is not found in TCM literature. Instead, it is classified and recorded under names such as "lactodermia," "milk rash," and "four-bend wind" based on similar clinical features (Liu Liang, Pi Xianming, Li Wenxia. Pathogenesis and TCM regulation of atopic dermatitis [J]. Shizhen Guoyi Guoyao, 2022, 33(6):1418-1420.). TCM believes that the pathogenesis of AD is mainly due to congenital intolerance, internal damp-heat in the five internal organs, spleen dysfunction and excessive heart fire, and external wind-damp-heat invasion of the skin, resulting in the disease due to the interaction between internal and external factors (Chen Yanhua. Clinical research progress of TCM in the treatment of atopic dermatitis [J]. China Traditional Chinese Medicine Modern Distance Education, 2023, 21(2):200-202.). In recent years, the incidence of atopic dermatitis has been increasing. The State Administration of Traditional Chinese Medicine has pointed out that the treatment of this disease is similar to that of acute, subacute, and chronic eczema, and should be based on syndrome differentiation and treatment according to different stages (State Administration of Traditional Chinese Medicine. Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine [S]. Nanjing: Nanjing University Press, 1994: 73-75). However, in actual clinical practice, the phenomenon of multiple syndrome types of atopic dermatitis occurring together is quite common, and single treatment is difficult to achieve ideal results. Therefore, modern TCM practitioners have summarized their clinical experience based on ancient literature, combined with syndrome differentiation and individual treatment, to carry out treatment of this disease from different aspects. Summary of the Invention

[0006] This invention represents a further optimization of the Zishui Qingxin Decoction, with the core treatment principle of "nourishing the kidneys and clearing the heart, eliminating stagnation and promoting circulation." It provides a traditional Chinese medicine composition for treating skin diseases that has fewer ingredients, a better taste, faster onset of action, higher safety, and better efficacy, offering a treatment option for patients with atopic dermatitis exhibiting symptoms of heart and spleen heat accumulation. Based on this, the invention was completed.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition, said traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-20 parts of Coptis chinensis, 5-50 parts of Rehmannia glutinosa, and / or 2-30 parts of Gardenia jasminoides. The herb is selected from one or more of the following: 5-30 parts hawthorn and / or 5-30 parts medicated leaven; The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-20 parts, Portulaca oleracea 10-90 parts, Atractylodes lancea 5-30 parts, Lonicera japonica 5-60 parts, Paeonia lactiflora 5-30 parts, Isatis indigotica 5-30 parts, Hordeum vulgare 5-30 parts, Dictamnus dasycarpus 5-30 parts, Ostrea gigas 5-45 parts, Scutellaria baicalensis 2-20 parts and / or Lophatherum gracile 2-20 parts. The medicine is selected from one or more of the following: 2-30 parts of Citrus aurantium, 2-15 parts of Raphanus sativus, and / or 2-10 parts of Areca catechu.

[0008] Preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-12 parts of Coptis chinensis, 5-30 parts of Rehmannia glutinosa, and / or 2-20 parts of Gardenia jasminoides. The herb is selected from one or more of hawthorn (5-20 parts) and / or medicated leaven (5-20 parts); The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-15 parts, Portulaca oleracea 10-60 parts, Atractylodes lancea 5-20 parts, Lonicera japonica 5-40 parts, Paeonia lactiflora 5-20 parts, Isatis indigotica 5-25 parts, Hordeum vulgare 5-20 parts, Dictamnus dasycarpus 5-20 parts, Ostrea gigas 5-30 parts, Scutellaria baicalensis 2-12 parts and / or Lophatherum gracile 2-15 parts. The medicine is selected from one or more of the following: 2-20 parts of Citrus aurantium, 2-10 parts of Raphanus sativus, and / or 2-8 parts of Areca catechu.

[0009] More preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-10 parts of Coptis chinensis, 5-25 parts of Rehmannia glutinosa, and / or 2-10 parts of Gardenia jasminoides. The herb is selected from one or more of hawthorn (5-15 parts) and / or medicated leaven (5-15 parts); The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-10 parts, Portulaca oleracea 10-30 parts, Atractylodes lancea 5-15 parts, Lonicera japonica 5-30 parts, Paeonia lactiflora 5-15 parts, Isatis indigotica 5-20 parts, Hordeum vulgare 5-15 parts, Dictamnus dasycarpus 5-15 parts, Ostrea gigas 5-20 parts, Scutellaria baicalensis 2-10 parts and / or Lophatherum gracile 2-10 parts. The medicine is selected from one or more of the following: 2-10 parts of Citrus aurantium, 2-8 parts of Raphanus sativus, and / or 2-6 parts of Areca catechu.

[0010] In some specific embodiments of the present invention, the traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-20 parts of Gardenia jasminoides, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Massa fermentata, 2-20 parts of Scutellaria baicalensis, 2-20 parts of Lophatherum gracile, 2-30 parts of Citrus aurantium, 5-20 parts of Uncaria rhynchophylla, 10-90 parts of Portulaca oleracea, and 5-60 parts of Lonicera japonica.

[0011] In some specific embodiments of the present invention, the traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-20 parts of Gardenia jasminoides, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Medicated Leaven, 2-20 parts of Scutellaria baicalensis, 2-20 parts of Lophatherum gracile, 2-30 parts of Citrus aurantium, 5-20 parts of Uncaria rhynchophylla, 10-90 parts of Portulaca oleracea, 5-60 parts of Lonicera japonica, 5-20 parts of Dictamnus dasycarpus, and 2-10 parts of Areca catechu.

[0012] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-20 parts of Gardenia jasminoides, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Massa fermentata, 2-20 parts of Scutellaria baicalensis, 2-20 parts of Lophatherum gracile, 2-30 parts of Citrus aurantium, 5-20 parts of Uncaria rhynchophylla, and 10-90 parts of Portulaca oleracea.

[0013] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-20 parts of Gardenia jasminoides, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Medicated Leaven, 2-20 parts of Scutellaria baicalensis, 5-30 parts of Isatis indigotica, 5-30 parts of Hordeum vulgare, 5-20 parts of Raphanus sativus seed, and 5-20 parts of Dictamnus dasycarpus root bark.

[0014] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-20 parts of Gardenia jasminoides, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Medicated Leaven, 2-20 parts of Scutellaria baicalensis, 5-30 parts of Isatis indigotica, 5-30 parts of Hordeum vulgare, 5-20 parts of Raphanus sativus, 5-30 parts of Paeonia lactiflora, and 5-20 parts of Dictamnus dasycarpus.

[0015] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-20 parts of Gardenia jasminoides, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Medicated Leaven, 2-20 parts of Scutellaria baicalensis, 5-30 parts of Isatis indigotica, 5-30 parts of Hordeum vulgare, 5-20 parts of Raphanus sativus, 5-30 parts of Ostrea gigas, and 5-20 parts of Uncaria rhynchophylla.

[0016] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-15 parts of Coptis chinensis, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Massa fermentata, 5-30 parts of Atractylodes lancea, 1-5 parts of Isatis indigotica, 5-20 parts of Raphanus sativus, 5-20 parts of Dictamnus dasycarpus, and 5-30 parts of Lonicera japonica.

[0017] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 5-50 parts of Rehmannia glutinosa, 2-15 parts of Coptis chinensis, 5-30 parts of Crataegus pinnatifida, 5-20 parts of Massa fermentata, 5-30 parts of Atractylodes lancea, 1-5 parts of Isatis indigotica, 5-20 parts of Raphanus sativus, 5-20 parts of Dictamnus dasycarpus, and 5-30 parts of raw oyster shell.

[0018] In a second aspect, the present invention provides a traditional Chinese medicine preparation made from the traditional Chinese medicine composition described in the first aspect, wherein the traditional Chinese medicine preparation is one or more of the following: ointment, pill, elixir, decoction, granule, capsule, powder and / or tablet.

[0019] Furthermore, the traditional Chinese medicine preparation is a decoction, and the preparation method of the decoction includes the following steps: S01: Prepare the Chinese herbal raw materials according to the required proportions; S02: Soak the Chinese herbal medicine raw materials prepared in S01; S03: Boil the raw materials and soaking liquid together several times; S04: Combine and concentrate the decoctions obtained from several decoctions to obtain a concentrated decoction, which is the decoction described in this application.

[0020] Furthermore, in step S02, the weight of the soaking solution added for the first time is 8 times the total weight of the raw materials, and the soaking time is 20-30 minutes; the weight of the soaking solution added for the second time is 6 times the total weight of the raw materials.

[0021] Furthermore, in step S03, the decocting process involves first boiling the raw materials and soaking liquid over high heat, and then reducing the heat to low and simmering for 20-30 minutes. The decocting process is repeated twice.

[0022] Furthermore, the traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required for the corresponding preparation.

[0023] Furthermore, the excipients are pharmaceutical excipients that enhance the efficacy of the active pharmaceutical ingredient, reduce its toxicity, and / or alleviate its side effects.

[0024] Thirdly, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect in the preparation of a medicament for treating skin diseases.

[0025] Furthermore, the skin diseases include atopic dermatitis, eczema, dermatitis, allergic dermatitis, and psoriasis.

[0026] Preferably, the skin disease is atopic dermatitis.

[0027] More preferably, the skin disease is atopic dermatitis with accumulation of heat in the heart and spleen.

[0028] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows: Rehmannia glutinosa: Sweet in taste and cold in nature. It enters the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid. It is used for heat entering the blood level, febrile rashes, hematemesis and epistaxis, yin deficiency due to febrile diseases, red tongue with thirst, constipation due to fluid depletion, yin deficiency fever, bone steaming fever, and internal heat with thirst.

[0029] Gardenia: Bitter in taste and cold in nature. It enters the heart, lung, and triple burner meridians. It has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying; externally, it reduces swelling and relieves pain. It is used for feverish irritability, damp-heat jaundice, painful urination, hematemesis and epistaxis due to blood heat, red and swollen eyes, and carbuncles caused by fire toxins; externally, it is used to treat sprains and contusions.

[0030] Hawthorn: Sour and sweet in taste, slightly warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion and strengthening the stomach, regulating qi and dispersing blood stasis, and resolving turbidity and lowering lipids. It is used for food stagnation due to excessive meat consumption, abdominal distension, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain, and hyperlipidemia.

[0031] Shenqu (Medicated Leaven): Sweet and pungent in taste, warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and stomach, promoting digestion and regulating the middle jiao (digestive system). It treats food stagnation, chest tightness and abdominal distension, vomiting and diarrhea, postpartum abdominal pain due to blood stasis, and abdominal distension and hard masses in children.

[0032] Scutellaria baicalensis: Bitter in taste and cold in nature. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used for damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, hematemesis and epistaxis due to blood heat, carbuncles and boils, and threatened abortion.

[0033] Lophatherum gracile: Sweet and bland in taste, cold in nature. It enters the heart, stomach, and small intestine meridians. It has the effects of clearing heat and purging fire, relieving irritability and quenching thirst, and promoting urination. It is used for feverish thirst, scanty and painful urination, and sores in the mouth and tongue.

[0034] Fructus Aurantii Immaturus: Bitter, pungent, and sour in taste, and slightly cold in nature. It enters the spleen and stomach meridians. It has the effects of regulating qi and relieving chest tightness, promoting circulation and relieving bloating. It is used for qi stagnation in the chest and hypochondrium, abdominal distension and pain, indigestion, phlegm retention, and organ prolapse.

[0035] Uncaria rhynchophylla: Sweet in taste and cool in nature. It enters the liver and pericardium meridians. It has the effects of calming wind and relieving convulsions, clearing heat and soothing the liver. It is used for internal wind in the liver, epilepsy and convulsions, high fever convulsions, colds with convulsions, infantile convulsions, eclampsia in pregnancy, headache and dizziness.

[0036] Purslane: Sour in taste and cold in nature. It enters the liver and large intestine meridians. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, and stopping dysentery. It is used for dysentery caused by heat toxins, carbuncles and boils, eczema, erysipelas, snake and insect bites, hematochezia, hemorrhoidal bleeding, and metrorrhagia.

[0037] Honeysuckle: Sweet in taste and cold in nature. It enters the lung, heart, and stomach meridians. It has the effects of clearing heat and detoxifying, and dispersing wind-heat. It is used for carbuncles, boils, sore throat, erysipelas, dysentery due to heat toxin, wind-heat cold, and febrile diseases.

[0038] Dictamnus dasycarpus root bark: Bitter in taste and cold in nature. It enters the spleen, stomach, and bladder meridians. It has the effects of clearing heat and drying dampness, dispelling wind and detoxifying. It is used for damp-heat sores, weeping eczema, urticaria, scabies, rheumatic arthralgia, jaundice, and dark urine.

[0039] Isatis leaf: Bitter in taste, cold in nature. It enters the heart and stomach meridians. It clears heat and detoxifies, cools the blood and eliminates rashes. It is used for febrile diseases with high fever, delirium, rashes, mumps, sore throat, erysipelas, and carbuncles.

[0040] Atractylodes lancea: pungent, bitter, and warm in nature. It enters the spleen, stomach, and liver meridians. It dries dampness, strengthens the spleen, dispels wind and cold, and improves eyesight. It is used for dampness obstructing the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatic pain, common cold due to wind-cold, night blindness, and blurred vision.

[0041] Raw oyster: Salty in taste, slightly cold in nature. It enters the liver, gallbladder, and kidney meridians. It has a calming and sedative effect, nourishes yin and yang, softens hardness and dissipates nodules. It is used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, and abdominal masses. Calcined oyster has astringent and consolidating properties, neutralizes acid and relieves pain. It is used for spontaneous sweating, night sweats, seminal emission, metrorrhagia, leukorrhea, stomach pain, and acid reflux.

[0042] Coptis chinensis: Bitter and cold in nature. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It clears heat and dries dampness, drains fire and detoxifies. It is used for damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever with delirium, excessive heart fire, restlessness and insomnia, palpitations, hematemesis due to blood heat, red eyes, toothache, thirst, carbuncles and boils; externally, it is used to treat eczema, damp sores, and ear discharge. Wine-processed Coptis chinensis is good at clearing heat from the upper burner. It is used for red eyes and mouth sores.

[0043] Peony root: Bitter and sour in taste, slightly cold in nature. It enters the liver and spleen meridians. It has the effects of calming the liver and cooling the blood, nourishing the blood and regulating menstruation, and astringing yin and stopping sweating. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache and dizziness.

[0044] Radish seed: pungent and sweet in taste, neutral in nature. It enters the lung, spleen, and stomach meridians. It aids digestion and relieves bloating, regulates qi and resolves phlegm. It is used for food stagnation, abdominal distension and pain, constipation, diarrhea due to food stagnation, and cough with phlegm accumulation.

[0045] Malt: Sweet in taste, neutral in nature. It enters the spleen and stomach meridians. It promotes digestion, strengthens the spleen and stomach, and relieves lactation and bloating. It is used for indigestion, abdominal distension and pain, poor appetite due to spleen deficiency, milk stasis, breast distension and pain, weaning, liver stagnation causing hypochondriac pain, and liver and stomach qi pain. Raw malt strengthens the spleen and stomach, and soothes the liver and promotes qi circulation. It is used for poor appetite due to spleen deficiency and milk stasis. Roasted malt promotes digestion, relieves indigestion, and relieves lactation. It is used for indigestion and weaning. Charred malt promotes digestion and resolves stagnation. It is used for indigestion and abdominal distension and pain.

[0046] Areca nut: Bitter in taste, pungent and warm in nature. It enters the stomach and large intestine meridians. It has the effects of killing parasites and eliminating food stagnation, regulating qi, promoting diuresis, and treating malaria. It is used for tapeworm, roundworm, and fascioliasis diseases, abdominal pain due to intestinal parasites, diarrhea due to food stagnation, tenesmus, edema, beriberi, and malaria.

[0047] The principles of this invention: Atopic dermatitis (AD) is often diagnosed as five syndromes: heart and spleen heat accumulation syndrome, heart fire and spleen deficiency syndrome, wind-damp heat accumulation syndrome, spleen deficiency and dampness accumulation syndrome, spleen deficiency and blood deficiency syndrome, and spleen and kidney yang deficiency syndrome. Traditional Chinese medicine (TCM) believes that the pathogenesis of AD is mainly due to congenital intolerance and acquired organ dysfunction, with "heart fire" and "spleen dysfunction" playing a crucial role throughout the entire course of AD. The *Treatise on the Spleen and Stomach* states: "When the spleen and stomach qi declines and the original qi is insufficient, the heart fire becomes excessive… fire and original qi cannot coexist; if one prevails, the other loses." This illustrates the key role of the pathological changes in the heart and spleen in the development of AD. The relationship between the heart and spleen is close. The spleen is the foundation of acquired constitution, the source of qi and blood production, and governs transportation and transformation. The normal functioning of the spleen and stomach affects the absorption of nutrients. The heart is the mother of the spleen, governing blood vessels; the nourishment of the heart blood is crucial for the normal physiological functioning of the spleen. Weak spleen and stomach function, impaired transportation and transformation, coupled with excessive heart fire, lead to insufficient absorption and utilization of nutrients by the body. This formula is an optimized version of Zishui Qingxin Yin, characterized by its pleasant taste, rapid onset of action, excellent efficacy, and high safety. The traditional Chinese medicine formula of this invention is based on the principle of nourishing the kidneys and clearing the heart, eliminating stagnation and promoting digestion. It uses Rehmannia glutinosa, Gardenia jasminoides, and Coptis chinensis as the principal herbs to nourish kidney water and clear heart fire. It uses Crataegus pinnatifida and Medicated Leaven as the assistant herbs to clear heat and purge fire, strengthen the spleen and stomach, and promote digestion and regulate the middle jiao. It uses Scutellaria baicalensis, Lophatherum gracile, Portulaca oleracea, Isatis indigotica, Atractylodes lancea, Lonicera japonica, Hordeum vulgare, Uncaria rhynchophylla, Paeonia lactiflora, Dictamnus dasycarpus, and Ostrea gigas as adjuvant herbs to guide heart fire downward, clear heat and detoxify, and relieve wind and itching. It uses Citrus aurantium and Raphanus sativus as guiding herbs to promote qi circulation and promote digestion.

[0048] Beneficial effects The herbal formula of this invention has the effect of rapidly reducing skin lesions and relieving itching in the treatment of mild to moderate AD patients. It has significant advantages in controlling recurrence and has good safety.

[0049] Currently, there is a lack of oral medications for treating atopic dermatitis or eczema in children and adolescents. The traditional Chinese medicine formula of this invention has significant efficacy in treating atopic dermatitis. In mild to moderate AD patients, its efficacy is superior to Zishui Qingxin Yin, and it has a better taste, making it easier for children to accept. It has good application prospects in the market. Attached Figure Description

[0050] Figure 1 The results of the initial physical examination and tongue and pulse diagnosis for typical case 1.

[0051] Figure 2 The results of the physical examination and tongue and pulse examination during the second follow-up visit of typical case 1.

[0052] Figure 3 Physical examination during the initial visit of typical case 2 Figure 4 Physical examination during the first follow-up visit of typical case 2 Figure 5 For the second follow-up physical examination of typical case 2 Figure 6 Physical examination during the initial visit of typical case 3 Figure 7 Physical examination during the first follow-up visit of typical case 3 Figure 8 For the second follow-up physical examination of typical case 3 Figure 9 Physical examination of typical case 4 during initial diagnosis Figure 10 For the second follow-up physical examination of typical case 4 Figure 11 Physical examination of typical case 5 during initial diagnosis Figure 12 For the first follow-up physical examination of typical case 5 Figure 13 For the second follow-up physical examination of typical case 5 Figure 14 Physical examination of typical case 6 during initial diagnosis Figure 15 Physical examination of typical case 6 during initial diagnosis Figure 16 For the second follow-up physical examination of typical case 6 Figure 17 Physical examination of typical case 7 during initial consultation Figure 18 For the first follow-up physical examination of typical case 7 Figure 19 The second physical examination for typical case 7 Detailed Implementation

[0053] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the embodiments described below can be combined with each other as long as they do not conflict with each other.

[0054] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, and the experimental materials used in the following embodiments are all available through conventional commercial channels.

[0055] Terminology Explanation The "Zi Shui Qing Xin Yin" of this invention is a traditional Chinese medicine composition as described in Chinese Patent CN 115054662 B, which is made from the following traditional Chinese medicines in parts by weight: The principal ingredient consists of the following: 10-30 parts of Rehmannia glutinosa and 5-25 parts of Gardenia jasminoides; the assistant ingredient consists of the following ingredients A or B: where A is: 5-20 parts of Scrophularia ningpoensis and 5-15 parts of Lophatherum gracile; where B is: 5-20 parts of Scrophularia ningpoensis and 5-15 parts of Lophatherum gracile, and one or two selected from 5-15 parts of chicken gizzard lining and 5-10 parts of Areca catechu; the adjuvant ingredient consists of the following ingredients C or D: C consists of: 5-20 parts of Uncaria rhynchophylla, 10-30 parts of Imperata cylindrica, and 5-15 parts of Crataegus pinnatifida; D consists of: 5-20 parts of Uncaria rhynchophylla, 10-30 parts of Imperata cylindrica, 5-15 parts of Crataegus pinnatifida, and one or more of the following: 5-15 parts of Lonicera japonica, 5-15 parts of Hordeum vulgare, 5-15 parts of Lycium chinense root bark, 1-5 parts of Juncus effusus, 5-30 parts of Portulaca oleracea, 5-15 parts of Forsythia suspensa, 5-30 parts of Ostrea gigas, 5-15 parts of Citrus reticulata peel, or 5-15 parts of Poria cocos.

[0056] Example 1: Traditional Chinese Medicine Composition Chinese herbal composition 1: 20g Rehmannia glutinosa, 10g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 6g Lophatherum gracile, 6g Citrus aurantium, 15g Uncaria rhynchophylla, 30g Portulaca oleracea, and 10g Lonicera japonica.

[0057] Chinese herbal composition 2: 15g Rehmannia glutinosa, 10g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 5g Scutellaria baicalensis, 5g Lophatherum gracile, 5g Citrus aurantium, 10g Uncaria rhynchophylla, 30g Portulaca oleracea, 15g Lonicera japonica, 15g Dictamnus dasycarpus, and 6g Areca catechu.

[0058] Traditional Chinese Medicine Composition 3: 30g Rehmannia glutinosa, 10g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 6g Isatis indigotica, 30g Hordeum vulgare, 20g Raphanus sativus, and 15g Dictamnus dasycarpus. Chinese herbal composition 4: 30g Rehmannia glutinosa, 10g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Scutellaria baicalensis, 15g Lophatherum gracile, 10g Citrus aurantium, 15g Uncaria rhynchophylla, and 60g Portulaca oleracea.

[0059] Chinese herbal composition 5 consists of 30g Rehmannia glutinosa, 15g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Scutellaria baicalensis, 10g Isatis indigotica, 30g Hordeum vulgare, 20g Raphanus sativus, 10g Paeonia lactiflora, and 15g Dictamnus dasycarpus.

[0060] Chinese herbal composition 6 consists of 30g Rehmannia glutinosa, 15g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 5g Scutellaria baicalensis, 10g Isatis indigotica, 30g Hordeum vulgare, 20g Raphanus sativus, 30g Ostrea gigas, and 20g Uncaria rhynchophylla.

[0061] Chinese herbal composition 7 consists of 30g Rehmannia glutinosa, 6g Coptis chinensis, 30g Crataegus pinnatifida, 20g Massa fermentata, 30g Atractylodes lancea, 5g Isatis indigotica, 20g Raphanus sativus, 10g Dictamnus dasycarpus, and 30g Lonicera japonica.

[0062] Chinese herbal composition 8 consists of 30g Rehmannia glutinosa, 5g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 20g Atractylodes lancea, 5g Isatis indigotica, 15g Raphanus sativus, 10g Dictamnus dasycarpus, and 30g raw oyster shell.

[0063] Preparation method Weigh the required Chinese medicinal materials according to the proportions, put them into a pot, add 8 times the amount of water and soak for 30 minutes, decoct for 25 minutes the first time, add 6 times the amount of water and decoct for 25 minutes the second time, combine the decoctions, concentrate and filter to 400 mL (for children, it can be concentrated to 150-200 mL).

[0064] Example 2 Clinical Study 1 1. Method This study employs a prospective, randomized, single-blind, controlled design to conduct a standardized clinical trial to verify the efficacy of an optimized TCM treatment regimen for atopic dermatitis (Siwanfeng) with heart and spleen heat accumulation syndrome.

[0065] 2. Research Subjects This study selected patients with atopic dermatitis (Siwanfeng) and heart and spleen heat accumulation syndrome from the outpatient departments of the Department of Dermatology at Huairou District Traditional Chinese Medicine Hospital and Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University as research subjects.

[0066] 3. Diagnostic criteria 3.1 Western Medicine Diagnostic Criteria Refer to the clinical diagnostic criteria for mild to moderate atopic dermatitis in the "Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis 2020 Edition" and "Chinese Clinical Dermatology".

[0067] The severity of atopic dermatitis was assessed using the SCORAD score: mild (SCORAD score 0-24), moderate (SCORAD score 25-50), and severe (SCORAD score >50).

[0068] 3.2 Traditional Chinese Medicine Diagnostic Criteria This document is drafted with reference to the "Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Atopic Dermatitis" (Chinese Journal of Integrated Traditional and Western Medicine Dermatology and Venereology, 2013) and the "Standards for Diagnosis and Efficacy Evaluation of Diseases in Traditional Chinese Medicine" (National Standard of Traditional Chinese Medicine). Heart and spleen heat accumulation syndrome: Recurrent erythema, edema, papules, vesicles, or nodules on the face, neck, elbows, popliteal fossa, and trunk, sometimes accompanied by erosion and exudation, and intense itching. Other symptoms include irritability, dry mouth, restless sleep, constipation or bowel movements every few days, a red tongue or a red tongue tip with prickles, a thick or greasy tongue coating, and a slippery pulse.

[0069] 4. Discharge Standards 4.1 Inclusion Criteria ① Meets the above-mentioned clinical diagnostic criteria for moderate atopic dermatitis in Western medicine (25 < SCORAD score ≤ 50); ② It meets the diagnostic criteria for the syndrome of heat accumulation in the heart and spleen; ③ Age 2-18 years old, gender not limited; ④ Good compliance; able to cooperate with the collection of clinical data; ⑤ No systemic use of glucocorticoids, immunosuppressants, biologics, or ultraviolet light was observed within the four weeks prior to the study; ⑥ No oral antihistamines were taken within one week prior to the study; ⑦ No glucocorticoids, calcineurin inhibitors, or phosphodiesterase 4 were used within one week prior to the study; ⑧ The individual or their guardian must sign an informed consent form (signed by the guardian on their behalf), voluntarily participate in the trial, and the informed consent process must comply with GCP regulations.

[0070] Those who meet all of the above conditions are eligible for inclusion and will be included in this study.

[0071] 4.2 Exclusion Criteria ① Patients with any other skin diseases that may interfere with the evaluation of test results; ② Individuals with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as autoimmune diseases, skin tumors, or mental illness; ③ Patients with concurrent severe skin or systemic infections; ④ Patients with a history of allergy to any component of the research drug; ⑤ Patients who cannot receive traditional Chinese medicine decoction treatment; ⑥ Patients who are participating in other drug clinical trials.

[0072] If any of the above criteria are met, the patient will be excluded and not included in this study.

[0073] 4.3 Exclusion Criteria ① Those who were mistakenly included but did not meet the inclusion criteria; ②Those who use other drugs or treatment plans during the treatment process, affecting the assessment of efficacy.

[0074] 4.4 Shedding Criteria ①Those who entered the trial treatment but ultimately did not complete the clinical observation; ② Those who did not have regular follow-up visits during treatment and were lost to follow-up for various reasons during the follow-up period; ③ Those who are unwilling to continue clinical trials during the treatment process.

[0075] 4.5 Standard for Complete Suspension ① Those who experience serious adverse reactions or allergic reactions during clinical trials; ② If, during the research process, it is found that the medication used not only fails to improve symptoms but also further aggravates the condition; or if there are significant errors in the experimental design; or if there are large deviations during the implementation process that make it impossible to evaluate the efficacy of the medication; ③ Researchers consider the necessity of terminating the trial from a medical perspective. 5. Grouping and Treatment 5.1 Grouping The subjects were divided into a treatment group and a control group.

[0076] 5.2 Randomization Scheme A computer randomly generates random numbers, and researchers collect medications according to the order in which participants are enrolled. After verifying and registering the prescription, the dispensing staff distributes the medication, emphasizes precautions, and the participants sign to receive their medication.

[0077] 5.3 Sampling Method The enrolled cases were randomly assigned to the experimental group and the control group in a 1:1 ratio.

[0078] 5.4 Sample Size This study was an exploratory study. Based on clinical experience and considering a clinical dropout rate of 20%, the total number of cases in the trial was 66 (33 in the treatment group and 33 in the control group).

[0079] 5.5 Treatment Methods Experimental group: Oral Chinese medicine combinations 1 and 2. After decocting the herbs in water, concentrate the combined liquid and filter it to 400 mL (for children, concentrate to 150-200 mL). Divide the liquid into two doses and take orally, half an hour after meals, once in the morning and once in the evening.

[0080] control group Apply Eloson cream (Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) topically, covering the affected skin with a thin, even layer. For the first two weeks, apply Eloson cream once daily. After two weeks, gradually reduce the frequency and amount of application based on the condition of the skin lesions. Avoid applying the medication to the face and body folds.

[0081] Treatment course: Four weeks. Patients returned for follow-up visits every week to record the degree of improvement in their condition. Health education was provided to both groups of children and their families, advising them to avoid spicy, irritating, and cold foods, avoid washing the affected area with hot water, and routinely apply topical moisturizers. 5.6 Blindness Medication collection: Patients' family members collect their medications at the clinical trial drug window according to their random number. The medications are distributed and registered by designated personnel.

[0082] 6. Evaluation of therapeutic effect 6.1 Primary efficacy endpoint – SCORAD score The SCORAD score, proposed by the European Atopic Dermatitis Study Group, is currently the most widely used disease severity scale in clinical research and practice. It mainly includes the extent of skin lesions (A), the severity of skin lesions (B), and the patient's subjective symptoms (C). Details are as follows (see Table 1): A. Calculate the extent of skin lesions: Front of the body: head 4.5%, trunk 18%, upper limb (unilateral) 4.5%, lower limb (unilateral) 9%; the calculation method for the back of the body is the same as that for the front; in addition, the vulva is 1%, for a total score of 100 points.

[0083] B. Severity of Skin Lesions: The severity of skin lesions is classified into four levels: none, mild, moderate, and severe, using a score of 0-3 for assessment. This is primarily assessed by evaluating erythema, papules / edema, crusting, lichenification / thickening, and epidermal peeling at the lesion site, as well as dryness of the skin in non-lesion areas.

[0084] C. Subjective Symptoms (Degree of Itching and Sleep Impact): The average level of itching over the past 3 days and the average degree of sleep impact over the past 3 nights were assessed based on the patient's actual condition, using a visual analog scale (see Appendix 1) for scoring. The specific scoring criteria are as follows: 0 points: no obvious itching; <3 points: itching sensation, but tolerable and does not affect sleep; 4-6 points: moderate itching sensation, still tolerable, but affects sleep; 7-10 points: severe itching sensation, unbearable for the patient, making it difficult to fall asleep. The formula for calculating the SCORAD score is: A / 5 + 7B / 2 + C.

[0085] Table 1 SCORAD Rating Scale 6.2 Research Evaluation Indicators Combined medication: If other medications are used in combination, they must be recorded in a timely manner. If they affect the trial, they should be excluded.

[0086] Adherence: During clinical trials, the facility maintains a system for counting remaining prescription drugs. After the trial, the investigator is responsible for counting the number of remaining prescription drugs for the subjects under their supervision to monitor the subjects' medication adherence.

[0087] 6.3 Efficacy Evaluation Criteria This was drafted in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (China Medical Science and Technology Press, 2002, 5).

[0088] The calculation formula (nimodipine method) is: Efficacy index = [(pre-treatment SCORAD total score - post-treatment SCORAD total score) / pre-treatment SCORAD total score] × 100%.

[0089] Therapeutic effect evaluation: Clinical cure: The rash has basically subsided, the symptoms have disappeared, and the efficacy rate is ≥90%; Significant effect: Most of the rash subsided, and symptoms were significantly improved; efficacy rate was 60% ≤ efficacy rate < 90%. Effective: The rash partially subsided, and symptoms improved; efficacy rate ≤ 20% < 60%. Ineffective: The rash does not subside significantly, symptoms do not improve or even worsen, and the efficacy rate is <20%; Overall effective rate = [(number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases] × 100%.

[0090] 7. Research Summary All cases that met the trial protocol, had good adherence, did not take prohibited medications during the trial, completed the required information in the CRF, or took 80% to 120% of the amount of investigational drug, were included in the protocol-compliant dataset statistical analysis for efficacy.

[0091] 8. Statistical Analysis and Content Statistical analysis will be performed using SPSS 22.0 statistical analysis software. All statistical tests will be two-tailed, and a p-value less than or equal to 0.05 will be considered statistically significant. Chi-square tests will be used for count data, and continuous data will be expressed as mean ± standard deviation (x ± s). Paired-samples t-tests will be used for within-group comparisons, and independent-samples t-tests will be used for between-group comparisons. The rank-sum test will be used for comparing ordinal data. Pearson correlation tests will be used for correlation analysis.

[0092] 9. Research Results 9.1 Case Data Cases were collected from patients visiting the Dermatology Outpatient Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between May 2023 and April 2024. After the Patient Case Report Form (CRF) was completed, two different data entry personnel entered and verified the data twice. A total of 66 patients were enrolled, with 5 dropping out due to personal reasons, resulting in 61 cases ultimately included in the statistical analysis. Of these, 31 were in the treatment group and 30 were in the control group.

[0093] 9.2 Baseline Data Of the 61 patients, 33 were male and 28 were female, with a mean age of 7.93 ± 3.87 years and a mean disease duration of 4.22 ± 3.65 years. Before treatment, the sex of the treatment and control groups was determined by a chi-square test. The patients' age and disease duration in both groups followed a normal distribution with homogeneous variances. An independent samples t-test indicated no significant difference between the two groups.

[0094] 9.3 Evaluation of therapeutic effect (a) SCORAD score The results are shown in Table 2. A paired t-test showed that the total SCORAD scores decreased in both the treatment and control groups before and after treatment, with statistically significant differences. P <0.05), while the total SCORAD score decreased more significantly in the treatment group, and the difference in SCORAD scores between the treatment group and the control group was statistically significant. P <0.05), indicating that the patients in the treatment group experienced more significant remission after 4 weeks.

[0095] (II) Overall efficacy evaluation The results are shown in Table 3. The SCORAD index of the two treatment groups was divided into four levels: cured, significantly effective, effective, and ineffective. The chi-square test was used for analysis. The experimental group had a total of 27 effective cases, with a total effective rate of 87.1%, while the control group had a total of 22 effective cases, with a total effective rate of 63.33%. The two groups were compared... P <0.05 indicates a statistically significant difference in efficacy between the two groups.

[0096] 9.4 Adverse Reactions No adverse reactions were observed in either the treatment group or the control group.

[0097] 10. Conclusion This clinical study demonstrates that the herbal composition of this invention can rapidly reduce skin lesions and relieve itching in the treatment of mild to moderate atopic dermatitis (AD) patients, and shows significant advantages in controlling recurrence. Furthermore, the herbal composition of this invention exhibits good safety. Currently, there is a lack of oral medications for treating atopic dermatitis or eczema in children or adolescents. This research confirms the significant efficacy of the herbal composition of this invention in treating atopic dermatitis. In mild to moderate AD patients, its efficacy is superior to Zishui Qingxin Yin (a traditional Chinese medicine), and it has a better taste, making it more easily accepted by children, thus showing promising application prospects in the market.

[0098] Example 3 Clinical Study 2 1. Method This study employs a prospective, randomized, single-blind, controlled design to conduct a standardized clinical trial to verify the efficacy of an optimized TCM treatment regimen for atopic dermatitis (Siwanfeng) with heart and spleen heat accumulation syndrome.

[0099] 2. Research Subjects This study selected patients with atopic dermatitis (Siwanfeng) and heart and spleen heat accumulation syndrome from the dermatology outpatient clinic of Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, as the research subjects.

[0100] 3. Diagnostic criteria 3.1 Western Medicine Diagnostic Criteria Refer to the clinical diagnostic criteria for mild to moderate atopic dermatitis in the "Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis 2020 Edition" and "Chinese Clinical Dermatology".

[0101] The severity of eczema was assessed using the Eczema Area and Severity Index (EASI): Mild: EASI score ≤ 7; Moderate: 7 < EASI score ≤ 21; Severe: EASI score > 21.

[0102] 3.2 Traditional Chinese Medicine Diagnostic Criteria This document is drafted with reference to the "Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Atopic Dermatitis" (Chinese Journal of Integrated Traditional and Western Medicine Dermatology and Venereology, 2013) and the "Standards for Diagnosis and Efficacy Evaluation of Diseases in Traditional Chinese Medicine" (National Standard of Traditional Chinese Medicine). Heart and Spleen Heat Accumulation Syndrome: Recurrent erythema, edema, papules, vesicles, or nodules on the face, neck, elbows, popliteal fossa, trunk, etc., which may be accompanied by erosion and exudation, and significant and severe itching. Symptoms include irritability, dry mouth, restless sleep, dry stools or bowel movements every few days, red tongue or red tongue tip or with prickles, thick or greasy tongue coating, and slippery pulse.

[0103] 4. Discharge Standards 4.1 Inclusion Criteria ① Meets the diagnostic criteria of both Western and Traditional Chinese Medicine; ② Age between 2 and 18 years old, gender not limited; ③ No systemic use of hormones, immunosuppressants, or ultraviolet radiation therapy within the past 4 weeks; ④ No systematic use of biological agents or targeted drugs within the past 3 months; ⑤ No systemic use of antihistamines within the past two weeks; ⑥ Obtain permission from the guardian, sign an informed consent form, and voluntarily participate in the trial.

[0104] 4.2 Exclusion Criteria ① Patients with any other skin diseases that may interfere with the evaluation of test results; ② Individuals with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as autoimmune diseases, skin tumors, or mental illness; ③ Patients with concurrent severe skin or systemic infections; ④ Patients with a history of allergy to any component of the research drug; ⑤ Patients who cannot receive treatment with traditional Chinese medicine compound preparations; ⑥ Patients who are participating in other drug clinical trials.

[0105] 4.3 Exclusion Criteria ① Those who were mistakenly included but did not meet the inclusion criteria; ②Those who use other drugs or treatment plans during the treatment process, affecting the assessment of efficacy.

[0106] 4.4 Shedding Criteria ①Those who entered the trial treatment but ultimately did not complete the clinical observation; ② Those who did not have regular follow-up visits during treatment and were lost to follow-up for various reasons during the follow-up period; ③ Those who are unwilling to continue clinical trials during the treatment process.

[0107] 4.5 Standard for Complete Suspension ① Those who experience serious adverse reactions or allergic reactions during clinical trials; ② If, during the research process, it is found that the medication used not only fails to improve symptoms but also further aggravates the condition; or if there are significant errors in the experimental design; or if there are large deviations during the implementation process that make it impossible to evaluate the efficacy of the medication; ③ Researchers consider the necessity of terminating the trial from a medical perspective. 5. Grouping and Treatment 5.1 Grouping The subjects were divided into an experimental group and a control group.

[0108] 5.2 Randomization Scheme A computer randomly generates random numbers, and researchers collect medications according to the order in which participants are enrolled. After verifying and registering the prescription, the dispensing staff distributes the medication, emphasizes precautions, and the participants sign to receive their medication.

[0109] 5.3 Sampling Method The enrolled cases were randomly assigned to the experimental group and the control group in a 2:1 ratio.

[0110] 5.4 Sample Size The PASS 11 software was used to calculate the sample size using the superiority clinical trial sample formula. Based on previous trials and literature review, the EASI75 efficacy rate was 32% in the control group and 65% in the experimental group, with α=0.05 and 1-β=0.80. The sample size was calculated as follows: 48 cases in the control group and 96 cases in the experimental group. Based on clinical experience and considering a 20% dropout rate, the total number of cases was 162, with 108 cases in the experimental group and 54 cases in the control group.

[0111] 5.5 Treatment Methods Experimental group 1: The patient was given oral administration of the traditional Chinese medicine composition 3, plus topical application of 0.1% mometasone furoate cream.

[0112] Experimental group 2: Administered oral Chinese medicine composition 4, plus topical application of 0.1% mometasone furoate cream. Experimental group 3: The patient was given a traditional Chinese medicine composition 5 orally, plus 0.1% mometasone furoate cream applied topically.

[0113] Experimental group 4: The patient was given a traditional Chinese medicine composition 6 orally, plus 0.1% mometasone furoate cream applied topically.

[0114] Experimental group 5: The patient was given a traditional Chinese medicine composition 7 orally, plus 0.1% mometasone furoate cream applied topically.

[0115] Experimental group 6: The patient was given oral administration of the traditional Chinese medicine composition 8, plus topical application of 0.1% mometasone furoate cream.

[0116] The traditional Chinese medicine compound is administered using an age-stratified dosing method, divided into three age groups: 2-6 years old, 7-12 years old, and 13-18 years old. The medicine is given orally according to the age group, with the components in a 2:3:4 ratio. Each dose is decocted into 100ml and taken orally twice a day, once in the morning and once in the evening.

[0117] Control group: Administered Eloson cream (Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) topically, applying a thin, even layer to the affected skin. For the first two weeks, Eloson cream was applied once daily; after two weeks, the frequency and amount of application were gradually reduced based on the condition of the skin lesions. Avoid applying the medication to the face and body folds.

[0118] Treatment duration: 4 weeks. Patients will return for follow-up visits every week to record the degree of improvement. Health education will be provided to both groups of children and their families, advising them to avoid spicy, irritating, and cold foods, avoid washing the affected area with hot water, and routinely apply topical moisturizers. The prepared herbal pieces were provided by Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University.

[0119] 5.6 Blindness Medication collection: Patients' family members collect their medications at the clinical trial drug window according to their random number. The medications are distributed and registered by designated personnel.

[0120] 6. Evaluation of therapeutic effect 6.1 Primary therapeutic indicators— Eczema Area and Severity Index (EASI) 6.2 Research Evaluation Indicators Combined medication: If other medications are used in combination, they must be recorded in a timely manner. If they affect the trial, they should be excluded.

[0121] Adherence: During clinical trials, the facility maintains a system for counting remaining prescription drugs. After the trial, the investigator is responsible for counting the number of remaining prescription drugs for the subjects under their supervision to monitor the subjects' medication adherence.

[0122] 6.3 Efficacy Evaluation Criteria Using the EASI75 achievement rate, the eczema area and severity index decreased by ≥75% from baseline.

[0123] 7. Research Summary All cases that met the trial protocol, had good adherence, did not take prohibited medications during the trial, completed the required information in the CRF, or took 80% to 120% of the amount of investigational drug, were included in the protocol-compliant dataset statistical analysis for efficacy.

[0124] 8. Statistical Analysis and Content Statistical analysis was performed using SPSS Statistics 25.0 software. For continuous data, if they conformed to a normal distribution, they were expressed as mean ± standard deviation (x±s), and comparisons between two groups were performed using independent samples t-tests. If they did not conform to a normal distribution, they were described using M(P25, P75), and comparisons between two groups were performed using nonparametric tests. Categorical data were described using percentages (%), and comparisons were performed using the chi-square test or Fisher's exact test. Ordinal data were compared using nonparametric tests. A p-value < 0.05 was considered statistically significant.

[0125] 9. Research Results 9.1 Case Data From September 2023 to September 2025, 162 children with atopic dermatitis exhibiting the syndrome of "heart and spleen heat accumulation" who visited Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, were randomly assigned to a control group and an experimental group using a random number table. The control group consisted of 54 patients, and the experimental group consisted of 108 patients. In the control group, 54 patients were enrolled, with 3 excluded due to poor compliance, resulting in 51 cases. In experimental group 1, 58 patients were enrolled, with 2 excluded due to poor compliance, resulting in 56 cases. Experimental groups 2, 3, 4, 5, and 6 each enrolled 10 patients, all of whom completed the study. In the control group, there were 28 males and 23 females; the mean age was (7.20±3.15) years; and the mean disease duration was (4.08±2.85) years. In experimental group 1, there were 50 males and 56 females; the mean age was (8.25±3.43) years; and the mean disease duration was (4.85±3.57) years. There were no statistically significant differences in general characteristics between the groups (P > 0.05). There were also no statistically significant differences between the groups (P > 0.05). This study was approved by the Clinical Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University (Approval No. BJZYYB-2023-72).

[0126] 9.2 Evaluation of therapeutic effect Table 4 shows a comparison of EASI scores before and after treatment in patients: Table 4 Comparison of EASI scores before and after treatment Table 5 shows the comparison of EASI75 levels before and after treatment in patients: Table 5 Comparison of EASI75 before and after treatment The experimental results are shown in Table 4. After treatment, the EASI scores of all groups decreased significantly, and the overall effect of the experimental group was better than that of the control group. After 4 weeks of treatment, the difference in the EASI75 target achievement rate between the experimental group and the control group was statistically significant. P <0.05), the experimental group was significantly better than the control group. As shown in Table 5, after treatment, there was no statistically significant difference between the experimental groups ( P >0.05), the pass rate of the experimental group was better than that of the control group.

[0127] 9.3 Adverse Reactions No adverse reactions were observed in either the treatment group or the control group.

[0128] 10. Conclusion This clinical study demonstrates that the herbal composition of this invention can rapidly reduce skin lesions and relieve itching in the treatment of mild to moderate atopic dermatitis (AD) patients, and shows significant advantages in controlling recurrence. Furthermore, the herbal composition of this invention exhibits good safety. Currently, there is a lack of oral medications for treating atopic dermatitis or eczema in children or adolescents. This research confirms the significant efficacy of the herbal composition of this invention in treating atopic dermatitis. In mild to moderate AD patients, its efficacy is superior to Zishui Qingxin Yin (a traditional Chinese medicine), and it has a better taste, making it more easily accepted by children, thus showing promising application prospects in the market.

[0129] Example 4 Typical Case Case 1 Patient: Male, 7 years old; Date of visit: December 17, 2024 Figure 1 ) Chief complaint: Rash all over body with itching for 2 years Present illness: Two years ago, the patient developed a rash without any obvious cause. Topical application of Eloson was ineffective. Current SCORAD score: 47.6. Symptoms include: Naco, preference for meat, cough, yellow phlegm, yellow nasal discharge, and bowel movements every 2-3 days. Tongue is red with a thick, greasy white coating, and pulse is slippery.

[0130] Past history: Good health; Allergy history: Allergic to eggs, milk, and kidney beans.

[0131] Physical examination: The skin is rough and dry, with numerous red papules on the body, accompanied by epidermal erosion, erosion and exudation, blood crusts, and scratch marks. The tongue is dark red with a white and greasy coating, and the pulse is slippery.

[0132] diagnosis: Traditional Chinese Medicine diagnosis: Four-bend wind—Heart and spleen heat accumulation syndrome; Western medicine diagnosis: Atopic dermatitis Prescriptions and treatments: 20g Rehmannia glutinosa, 10g Gardenia jasminoides, 6g Lophatherum gracile, 30g Portulaca oleracea, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Citrus aurantium, 6g Scutellaria baicalensis, 10g Lonicera japonica, 15g Uncaria rhynchophylla (added later). Nourishes water, clears the heart, and promotes digestion. Follow-up visit 1: December 31, 2023 After two weeks of treatment, the itching significantly decreased, and some skin lesions subsided, leaving pigmentation. Pale red patches remained on the neck with a few crusts. A few scattered red papules, scratch marks, and blood crusts were observed on the trunk and limbs. SCORAD score: 24.2. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery. Treatment and medication remained the same.

[0133] Second follow-up visit: January 7, 2024 Figure 2 ) After 4 weeks of treatment, mild itching persisted, and most skin lesions subsided. A very small number of red papules, a few scratch marks, and blood scabs remained scattered on the trunk and limbs. SCORAD score: 4.5. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery.

[0134] Case 2 Zhang XX Gender: female age: 2 years and 5 months; Initial consultation date: November 12, 2024 Figure 3 ) Chief complaint: The patient had a history of generalized erythema, desquamation, and itching for 2 years, with a recurrence and worsening of symptoms over the past week.

[0135] Present illness: The patient developed the condition in childhood, presenting with a rash all over the body, accompanied by itching. The rash gradually increased in number. The patient visited a local hospital and was diagnosed with eczema and atopic dermatitis. Oral loratadine syrup and traditional Chinese medicine were prescribed, along with topical application of acetaminophen and mupirocin ointment, but the effects were unsatisfactory, and the condition recurred frequently. One week ago, the condition worsened, with widespread red and light red patches appearing on the head, neck, trunk, and limbs, along with scratch marks and scabs. Appetite was normal, but bowel movements and urination were normal. The patient was restless and agitated. EASI: 29.5. NRS score: pruritus 6, sleep VAS 8. 。 Past history: none. Family history: Mother has a history of allergic rhinitis, psoriasis, and urticaria. Allergy history: milk.

[0136] Physical examination: Red or light red patches, scratches, and scabs are present on the head, neck, trunk, and limbs. The tongue is red with a white coating. The pulse is slippery. diagnosis: Western medicine: Atopic dermatitis (severe); Traditional Chinese medicine: Four-bend wind-heat syndrome of the heart and spleen Prescriptions and treatments: 15g Rehmannia glutinosa, 6g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 8g Isatis indigotica, 15g Hordeum vulgare, 6g Raphanus sativus seed, and 10g Dictamnus dasycarpus root bark. 14 doses in total. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0137] Follow-up appointment date: November 24, 2024 Figure 4 ) Present illness: AD returned for follow-up visit. Itching and sleep were significantly reduced. EASI: 15.4. VAS score: itching 3 points, sleep 3 points. Much quieter at the time of visit. A few light red patches on the face, elbows, and popliteal fossa; generalized erythema, dry, with reduced scaling, less scratching and scabs; minor epidermal erosion, no exudation. Appetite is good; bowel movements 2-3 times per day. Physical examination: A few pale red patches on the face, elbows, and popliteal fossa; generalized erythema, dry, with reduced scaling, lessening of scratch marks and scabs; minor epidermal erosion, no exudation. Pale red tongue with white coating. Slippery pulse.

[0138] diagnosis: Western medicine: Atopic dermatitis (moderate); Traditional Chinese medicine: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescriptions and treatments: 15g Rehmannia glutinosa, 6g Gardenia jasminoides, 15g Crataegus pinnatifida, 15g Massa fermentata, 6g Scutellaria baicalensis, 5g Isatis indigotica, 15g Hordeum vulgare, 6g Raphanus sativus seed, and 6g Dictamnus dasycarpus root bark. 14 doses in total. To nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0139] Follow-up appointment date: December 7, 2024 Figure 5 ) Present illness: AD returned for follow-up visit; itching relieved, rash partially subsided. EASI: 6.8. VAS score: itching 1 point, sleep 2 points. Currently, the patient has a light red rash all over the body, is dry, with reduced scaling, less scratch marks and scabs, a small amount of epidermal erosion, reduced ankle edema, and no exudation. He was all smiles. Naco has 2-3 bowel movements a day, occasionally unformed.

[0140] Physical examination: A few pale red patches in the popliteal fossa. Red tongue with a thin white coating. Slippery pulse.

[0141] diagnosis: Western medicine: Atopic dermatitis (mild); Traditional Chinese medicine: Four-bend wind-heart-fire-spleen accumulation syndrome Prescriptions and treatments: 10g Rehmannia glutinosa, 3g Gardenia jasminoides, 12g Crataegus pinnatifida, 12g Massa fermentata, 3g Scutellaria baicalensis, 8g Isatis indigotica, 10g Hordeum vulgare, 6g Raphanus sativus, and 5g Dictamnus dasycarpus root bark. Continue maintenance treatment. A total of 14 doses. Tonifies the kidneys, clears the heart, invigorates the spleen, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0142] Case 3: Patient: Wang X, male, 10 years old; Date of visit: December 17, 2024 Figure 6 ) Chief complaint: A 6-year history of body rash accompanied by itching, which has worsened in the past 4 weeks. Present illness: Six years ago, the patient developed a rash without any obvious cause. Topical application of Elosone provided temporary relief, but the rash recurred after discontinuation of the medication. Four weeks ago, the rash worsened after a cold. Currently, the rash is mainly scattered red and light red patches and papules on the extremities, accompanied by epidermal erosion and scratch marks. Some lesions are rough and thickened. Appetite is good, but stools are slightly dry. EASI score: 6.8. Pruritus NRS score: 6. Sleep VAS score: 4.

[0143] Past history: Allergic rhinitis; Family history: No special features; Allergy history: Nothing special.

[0144] Physical examination:The skin is rough and dry, with scattered red and light red patches and papules mainly on the limbs, accompanied by epidermal erosion and scratch marks. Some skin lesions are rough and thickened. The tongue is red with a thick white coating, and the pulse is slippery.

[0145] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescriptions and treatments: 15g Rehmannia glutinosa, 10g Gardenia jasminoides, 12g Crataegus pinnatifida, 12g Massa fermentata, 10g Scutellaria baicalensis, 10g Lophatherum gracile, 10g Citrus aurantium, 15g Uncaria rhynchophylla, 30g Portulaca oleracea. 14 doses in total. Nourishes water, clears the heart, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0146] Follow-up visit 1: December 31, 2023 Figure 7 ) After two weeks of treatment, itching was significantly reduced, and some skin lesions had subsided, with only a few scratch marks remaining. A few scattered red papules, scratch marks, and blood crusts were observed on the limbs. EASI score: 3.2. Pruritus NRS score: 3. Sleep VAS score: 2.

[0147] Nake, one bowel movement per day. Red tongue, white coating, slippery pulse.

[0148] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescriptions and treatments: 15g Rehmannia glutinosa, 10g Gardenia jasminoides, 12g Crataegus pinnatifida, 12g Massa fermentata, 10g Scutellaria baicalensis, 10g Lophatherum gracile, 10g Citrus aurantium, 15g Uncaria rhynchophylla, 30g Portulaca oleracea. 14 doses in total. Nourishes water, clears the heart, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0149] Second follow-up visit: January 7, 2024 Figure 8 ) After 4 weeks of treatment, mild itching and most skin lesions subsided. EASI score: 0.1. Pruritus NRS score: 1. Sleep VAS score: 0. Appetite: normal, bowel movements once a day. Tongue: red, coating: white, pulse: slippery.

[0150] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescriptions and treatments: 10g Rehmannia glutinosa, 6g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 5g Scutellaria baicalensis, 6g Lophatherum gracile, 6g Citrus aurantium, 10g Uncaria rhynchophylla, 15g Portulaca oleracea. 14 doses in total. Nourishes the kidneys, clears the heart, invigorates the spleen, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0151] Case 4 Guo XX Gender: male age: 5 years and 6 months; Initial consultation date: November 17, 2024 Figure 9 ) Chief complaint: The patient had a history of erythema, desquamation, and itching all over the body for 5 years, with a recurrence and worsening of symptoms over the past 2 weeks.

[0152] Present illness: The patient developed the condition in childhood, experiencing a rash all over her body that was itchy and gradually increased in number. She sought medical attention at a local hospital and was diagnosed with "atopic dermatitis." She was prescribed oral antihistamines and traditional Chinese medicine, as well as topical tacrolimus and mupirocin ointment, but the treatment was ineffective and the condition recurred frequently. One week ago, the condition worsened, with widespread red patches and papules appearing on her head, neck, trunk, and limbs, along with scratch marks, scabs, and constipation. 。 EASI: 12.2. NRS score: pruritus 6, sleep VAS 6. 。 Past history: none. Family history: Mother has a history of allergic rhinitis. Allergy history: none.

[0153] Physical examination: Red patches, papules, scratch marks, and scabs appear on the head, neck, trunk, and limbs. The tongue is red with a thick white coating.

[0154] Slippery pulse diagnosis: Western medicine: Atopic dermatitis (moderate); Traditional Chinese medicine: Four-bend wind-heat syndrome of the heart and spleen Prescriptions and treatments: 20g Rehmannia glutinosa, 8g Gardenia jasminoides, 12g Crataegus pinnatifida, 12g Massa fermentata, 8g Scutellaria baicalensis, 8g Isatis indigotica, 12g Hordeum vulgare, 10g Raphanus sativus, 10g Paeonia lactiflora, 10g Dictamnus dasycarpus root bark. 14 doses in total. Nourishes the kidneys, clears the heart, invigorates the spleen, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice daily. Follow-up appointment date: November 30, 2024 Present illness: AD returned for follow-up visit. Itching and sleep significantly reduced. EASI: 6.2. VAS score: itching 3 points, sleep 3 points. A few red patches on the face and limbs, generalized erythema, scratch marks and scabs reduced, minor epidermal erosion. Appetite good, bowel movements normal.

[0155] Physical examination: A few red patches on the face and limbs, erythema all over the body, scratches and scabs have lessened, and a small amount of epidermal erosion has occurred.

[0156] Pale red tongue with white coating. Slippery pulse. diagnosis: Western medicine: Atopic dermatitis (mild); Traditional Chinese medicine: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescriptions and treatments:15g Rehmannia glutinosa, 8g Gardenia jasminoides, 12g Crataegus pinnatifida, 12g Massa fermentata, 8g Scutellaria baicalensis, 8g Isatis indigotica, 12g Hordeum vulgare, 10g Raphanus sativus, 10g Paeonia lactiflora, 6g Dictamnus dasycarpus root bark. 14 doses in total. Nourishes the kidneys, clears the heart, invigorates the spleen, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0157] Follow-up appointment date: December 12, 2024 Figure 10 ) Present illness: AD follow-up visit: itching relieved, rash subsided. EASI: 0.2. VAS score: itching 0, sleep 0. Natriuretic intake, bowel movements normal.

[0158] Physical examination: Slight pigmentation. Red tongue with white coating. Slippery pulse. diagnosis: Western medicine: Atopic dermatitis (mild); Traditional Chinese medicine: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescriptions and treatments: 10g Rehmannia glutinosa, 4g Gardenia jasminoides, 8g Crataegus pinnatifida, 8g Massa fermentata, 4g Scutellaria baicalensis, 3g Isatis indigotica, 8g Hordeum vulgare, 5g Raphanus sativus, 5g Paeonia lactiflora, and 5g Dictamnus dasycarpus root bark. Continue maintenance treatment. Nourish the kidneys, clear the heart, invigorate the spleen, and promote digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice daily. Example 5: Patient: Female, 12 years old; Date of visit: December 17, 2024 Figure 11 ) Chief complaint: A patient has had a rash all over their body with itching for 8 years, which has worsened in the last 3 weeks. Present illness: Eight years ago, the patient developed a rash and was diagnosed with atopic dermatitis at another hospital. Topical corticosteroids, tacrolimus, and antibiotic ointments were used, but the rash fluctuated in severity. Three weeks ago, the rash worsened after staying up late. Current EASI score: 7.9. Pruritus NRS score: 8. Sleep VAS score: 6. Appetite is good, bowel movements occur every two days. Tongue is red with a white coating, and pulse is slippery.

[0159] Past history: Allergic rhinitis; Allergy history: Pollen and dust mite allergies.

[0160] Physical examination: Multiple red or light red patches and papules appear on the face, limbs, accompanied by scratch marks and blood crusts. The tongue is red with a white coating, and the pulse is slippery.

[0161] diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescriptions and treatments: 15g Rehmannia glutinosa, 10g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Medicated Leaven, 10g Scutellaria baicalensis, 10g Isatis indigotica, 10g Hordeum vulgare, 10g Radish seed, 30g Ostrea gigas, 15g Uncaria rhynchophylla (added later). 14 doses in total. Nourishes water, clears the heart, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0162] Follow-up visit 1: December 31, 2023 Figure 12 ) After two weeks of treatment, itching was significantly reduced, skin lesions were lighter in color, and scratch marks and scabs decreased. EASI score: 4.2. Pruritus NRS score: 4. Sleep VAS score: 3. Appetite was good, and bowel movements were once a day. Tongue was red with a white coating, and pulse was slippery.

[0163] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescription: 20g of Rehmannia glutinosa, 10g of Gardenia jasminoides, 10g of Crataegus pinnatifida, 10g of Medicated Leaven, 10g of Scutellaria baicalensis, 15g of Isatis indigotica, 10g of Hordeum vulgare, 10g of Raphanus sativus, 30g of raw Ostrea gigas, and 15g of Uncaria rhynchophylla (added later). A total of 14 doses.

[0164] Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0165] Second follow-up visit: January 7, 2024 Figure 13 ) After 4 weeks of treatment, mild itching and most skin lesions subsided. EASI score: 0.4. Pruritus NRS score: 1. Sleep VAS score: 0. Appetite: normal, bowel movements once a day. Tongue: red, coating: white, pulse: slippery.

[0166] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescription: 12g Rehmannia glutinosa, 6g Gardenia jasminoides, 10g Crataegus pinnatifida, 10g Massa fermentata, 6g Scutellaria baicalensis, 5g Isatis indigotica, 10g Hordeum vulgare, 10g Radish seed, 20g Ostrea gigas, 10g Uncaria rhynchophylla (added later). 14 doses in total.

[0167] Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0168] Example 6: Patient: Male, 9 years old Date of visit: December 17, 2024 Figure 14 , 15 ) Chief complaint: A 5-year history of body rash accompanied by itching, which has worsened in the past 2 weeks. Present illness: Five years ago, the patient developed a rash and was diagnosed with atopic dermatitis at another hospital. Topical corticosteroids and antibiotic ointments were used, but the rash fluctuated in severity. Two weeks ago, the rash worsened after consuming snacks. Current EASI score: 14.5. Pruritus NRS score: 7. Sleep VAS score: 6. Appetite is good, bowel movements occur every two days. Tongue is red with a thick white coating, and pulse is slippery.

[0169] Past history: Allergic rhinitis; Allergy history: Dust mite allergy.

[0170] Physical examination: Multiple red patches and papules on the limbs, accompanied by significant epidermal erosion, mild erosion and exudation, blood crusts, and scratch marks. The tongue is red with a white, greasy coating, and the pulse is slippery.

[0171] diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescriptions and treatments: 20g Rehmannia glutinosa, 5g Coptis chinensis, 15g Crataegus pinnatifida, 15g Massa fermentata, 12g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 10g Dictamnus dasycarpus, 30g Lonicera japonica. 14 doses in total. Nourishes water, clears the heart, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0172] Follow-up visit 1: December 31, 2023 After two weeks of treatment, itching was significantly reduced, skin lesions partially subsided, and erosion and exudation were significantly reduced. A few scattered red patches and papules, a few scratch marks and blood scabs were observed on the limbs. EASI score: 8.3. Pruritus NRS score: 4. Sleep VAS score: 3. Appetite was good, bowel movements were once a day. Tongue was red with a white coating, and pulse was slippery.

[0173] diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 10g Dictamnus dasycarpus, 20g Lonicera japonica. A total of 14 doses.

[0174] Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0175] Second follow-up visit: January 7, 2024 Figure 16 ) After 4 weeks of treatment, mild itching persisted, and most skin lesions subsided. A very small number of red papules, a few scratch marks, and blood scabs remained scattered on the trunk and limbs. EASI score: 1.2. Pruritus NRS score: 1. Sleep VAS score: 0. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery.

[0176] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 15g Crataegus pinnatifida, 15g Massa fermentata, 10g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 5g Dictamnus dasycarpus, 10g Lonicera japonica, for a total of 14 doses.

[0177] Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0178] Example 7: Patient: Male, 11 years old; Date of visit: July 30, 2024 Figure 17 ) Chief complaint: Redness and papules with itching on the limbs for 1 year, worsening in the past week. Present illness: One year ago, the patient developed a rash after being bitten by mosquitoes. The rash was recurrent and gradually spread to the limbs. An external hospital diagnosed it as atopic dermatitis. Topical corticosteroids and antibiotic ointments were used, but the skin lesions fluctuated in severity. One week ago, the rash worsened again. Currently, scattered red patches, papules, and nodules are present on the limbs. EASI score: 10.6. Pruritus NRS score: 7. Sleep VAS score: 6. Appetite is good; bowel movements occur every two days. Tongue is red with a thick white coating; pulse is slippery.

[0179] Past history: Allergic rhinitis; Allergy history: hay fever.

[0180] Physical examination: Multiple red patches, papules, and nodules appear on the limbs, accompanied by scratch marks and blood crusts. The tongue is red with a white, greasy coating, and the pulse is slippery.

[0181] diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescriptions and treatments: 20g Rehmannia glutinosa, 5g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 15g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 12g Dictamnus dasycarpus root bark, 30g raw oyster shell. 14 doses in total. Nourishes water, clears the heart, and promotes digestion. Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0182] Follow-up visit 1: December 31, 2023 Figure 18 ) After two weeks of treatment, itching significantly decreased, skin lesions gradually flattened and shrank, and scratch marks and scabs lessened. A few scattered red patches, nodules, and papules, along with a few scratch marks and scabs, were observed on the limbs. EASI score: 7.3. Pruritus NRS score: 4. Sleep VAS score: 3. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and pulse was slippery.

[0183] diagnosis: Western medicine diagnosis: Atopic dermatitis (moderate); Traditional Chinese medicine diagnosis: Four-sided wind-heat accumulation syndrome of the heart and spleen. Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 12g Atractylodes lancea, 10g Isatis indigotica, 10g Raphanus sativus, 12g Dictamnus dasycarpus, 30g Ostrea gigas. A total of 14 doses.

[0184] Usage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice a day.

[0185] Second follow-up visit: January 7, 2024 Figure 19 ) After 4 weeks of treatment, mild itching and partial resolution of skin lesions were observed. A few scattered red nodules and papules, along with a few scratch marks and scabs, were visible on the extremities. EASI score: 3.6. Pruritus NRS score: 2. Sleep VAS score: 0. Appetite was good, and bowel movements occurred once daily. Tongue was red with a white coating, and the pulse was slippery.

[0186] diagnosis: Western medicine diagnosis: Atopic dermatitis (mild); Traditional Chinese medicine diagnosis: Four-sided wind-heat syndrome of the heart and spleen. Prescription: 15g Rehmannia glutinosa, 3g Coptis chinensis, 20g Crataegus pinnatifida, 20g Massa fermentata, 10g Atractylodes lancea, 8g Isatis indigotica, 10g Raphanus sativus, 10g Dictamnus dasycarpus, 20g Ostrea gigas. Total 14 doses. Dosage: One dose per day, decocted in water and taken warm; Dosage: 100 mL, twice daily.

Claims

1. A traditional Chinese medicine composition, said traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-20 parts of Coptis chinensis, 5-50 parts of Rehmannia glutinosa, and / or 2-30 parts of Gardenia jasminoides. The herb is selected from one or more of the following: 5-30 parts hawthorn and / or 5-30 parts medicated leaven; The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-20 parts, Portulaca oleracea 10-90 parts, Atractylodes lancea 5-30 parts, Lonicera japonica 5-60 parts, Paeonia lactiflora 5-30 parts, Isatis indigotica 5-30 parts, Hordeum vulgare 5-30 parts, Dictamnus dasycarpus 5-30 parts, Ostrea gigas 5-45 parts, Scutellaria baicalensis 2-20 parts and / or Lophatherum gracile 2-20 parts. The medicine is selected from one or more of the following: 2-30 parts of Citrus aurantium, 2-15 parts of Raphanus sativus, and / or 2-10 parts of Areca catechu.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-12 parts of Coptis chinensis, 5-30 parts of Rehmannia glutinosa, and / or 2-20 parts of Gardenia jasminoides. The herb is selected from one or more of hawthorn (5-20 parts) and / or medicated leaven (5-20 parts); The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-15 parts, Portulaca oleracea 10-60 parts, Atractylodes lancea 5-20 parts, Lonicera japonica 5-40 parts, Paeonia lactiflora 5-20 parts, Isatis indigotica 5-25 parts, Hordeum vulgare 5-20 parts, Dictamnus dasycarpus 5-20 parts, Ostrea gigas 5-30 parts, Scutellaria baicalensis 2-12 parts and / or Lophatherum gracile 2-15 parts. The medicine is selected from one or more of the following: 2-20 parts of Citrus aurantium, 2-10 parts of Raphanus sativus, and / or 2-8 parts of Areca catechu.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: The principal ingredient is selected from one or more of the following: 5-10 parts of Coptis chinensis, 5-25 parts of Rehmannia glutinosa, and / or 2-10 parts of Gardenia jasminoides. The herb is selected from one or more of hawthorn (5-15 parts) and / or medicated leaven (5-15 parts); The adjuvant herbs are selected from one or more of the following: Uncaria rhynchophylla 5-10 parts, Portulaca oleracea 10-30 parts, Atractylodes lancea 5-15 parts, Lonicera japonica 5-30 parts, Paeonia lactiflora 5-15 parts, Isatis indigotica 5-20 parts, Hordeum vulgare 5-15 parts, Dictamnus dasycarpus 5-15 parts, Ostrea gigas 5-20 parts, Scutellaria baicalensis 2-10 parts and / or Lophatherum gracile 2-10 parts. The medicine is selected from one or more of the following: 2-10 parts of Citrus aurantium, 2-8 parts of Raphanus sativus, and / or 2-6 parts of Areca catechu.

4. A traditional Chinese medicine preparation made from the traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine preparations are one or more of the following: ointment, pill, elixir, decoction, granule, capsule, powder, and / or tablet.

5. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The preparation is a decoction, and the preparation method of the decoction includes the following steps: S01: Prepare the Chinese herbal raw materials according to the required proportions; S02: Soak the Chinese herbal medicine raw materials prepared in S01; S03: Boil the raw materials and soaking liquid several times; S04: Combine and concentrate the decoction obtained from several decoctions to obtain a decoction.

6. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required for the corresponding preparation; the excipients are pharmaceutical excipients that enhance the efficacy, reduce toxicity, and / or alleviate the side effects of the main drug.

7. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for treating skin diseases, characterized in that, The skin diseases mentioned include atopic dermatitis, eczema, dermatitis, allergic dermatitis, and psoriasis.

8. The application as described in claim 7, characterized in that, The skin condition described is atopic dermatitis.

9. The application as described in claim 7, characterized in that, The atopic dermatitis mentioned is a syndrome of accumulated heat in the heart and spleen.

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