A traditional Chinese medicine composition for treating skin diseases

Abstract

The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating skin diseases and application thereof. The traditional Chinese medicine composition takes the core principle of 'nourishing kidney and strengthening spleen, and promoting lung and removing dampness' as the core principle, provides a traditional Chinese medicine for treating skin diseases with fast effect, high safety and better curative effect, and provides an optimized scheme for treating atopic dermatitis or eczema for patients with spleen-kidney deficiency, lung depression and dampness accumulation. The kidney-nourishing and spleen-strengthening lung-promoting drink has a significant curative effect on atopic dermatitis, has a better taste, is more easily accepted by children, and has a good application prospect in the market.

Description

Technical Field

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

[0002] Atopic dermatitis (AD), also known as atopic eczema, atopic dermatitis, hereditary allergic dermatitis, etc., is called "Siwanfeng" in traditional Chinese medicine, and is also known as milk rash, fetal sores, etc. It is a common chronic, recurrent, itchy skin disease. It usually occurs in infancy or childhood and can persist into adulthood. The incidence rate in infants under 1 year old in 12 cities in my country is as high as 35%, while epidemiological studies abroad show that about 15% to 20% of children worldwide suffer from atopic dermatitis. Its exact etiology and pathogenesis are not yet fully understood, but current research suggests that it is mainly related to multiple factors such as genetics, environment, abnormal skin barrier function, and immune imbalance. This "atopic" condition, which occurs from childhood and is related to genetics, is what traditional Chinese medicine refers to as "inherent intolerance." The *Leijing* states: "The inherent endowment is the foundation of the fetal origin, which is the essence and qi received from the parents." The inherent endowment is formed from the reproductive essence of both parents, namely "kidney essence." Kidney essence deficiency and congenital imbalances, along with differences in Yin and Yang and functional activities in the parents' bodies, can lead to similar predispositions in offspring. Modern pathophysiological studies have also found that genetic factors can cause immune disorders and impaired skin barrier function in patients with atopic dermatitis, which is intrinsically consistent with the concept of "inherent intolerance" in Traditional Chinese Medicine. With the continuous accumulation of clinical experience, modern physicians, based on the etiology and pathogenesis of atopic dermatitis and considering different clinical symptoms, have classified it into four syndrome types: Spleen Deficiency with Dampness Accumulation, Damp-Heat Accumulation, Blood Deficiency with Wind-Dryness, and Qi Stagnation with Blood Stasis. The *International Guidelines for Clinical Practice in Traditional Chinese Medicine: Atopic Dermatitis* further subdivides atopic dermatitis into six syndrome types: Heart and Spleen Heat Accumulation, Heart Fire and Spleen Deficiency, Spleen Deficiency with Dampness Accumulation, Wind-Damp-Heat Accumulation, Spleen Deficiency with Blood Dryness, and Spleen and Kidney Yang Deficiency, providing new references for the clinical classification and treatment of atopic dermatitis.

[0003] Currently, Western medicine primarily uses topical corticosteroids as first-line treatment for atopic dermatitis. While these medications provide short-term control, relapses often occur after discontinuation, making a complete cure difficult. With advancements in modern medicine, treatment for atopic dermatitis has evolved to include biologics, such as duplerumab. These treatments often improve the condition in many patients, but they also have drawbacks: slow onset of action, high cost, unknown long-term risks, lack of detailed data on their use in children, and the risk of relapse after discontinuation. This is because modern medical treatments target the symptoms within the context of modern pathogenesis, while the initiating factors of the disease remain unclear, making a complete cure challenging. Traditional Chinese medicine (TCM) offers certain advantages in treating atopic dermatitis (AD), not only controlling the condition and reducing or delaying relapses but also improving patients' quality of life.

[0004] Based on the Zhao family's dermatology tradition and their own clinical experience, the inventors discovered that children with Alzheimer's disease (AD) often present with red papules and patches on the face, trunk, and limbs, which may be accompanied by erosion, exudation, epidermal peeling, and itching. They also frequently experience halitosis, constipation, irritability, poor sleep, a red tongue with a white or thick, greasy coating, and a thready, slippery pulse. Combining this with the physiological characteristics of the five internal organs in children and based on the "water and fire in balance" theory of the I Ching, they proposed that kidney essence deficiency is the core factor throughout AD, excessive heart fire is the initiating factor, and gastrointestinal stagnation and spleen dysfunction are important causes. Due to prolonged illness or differences in constitution, spleen deficiency leads to impaired water metabolism. The lungs govern the body's Qi and water metabolism; internal retention of dampness affects lung function, leading to lung Qi stagnation. Simultaneously, spleen and kidney deficiency can also lead to insufficient lung Qi, resulting in impaired lung fluid distribution and the accumulation of dampness. Patients with this type of spleen and kidney deficiency and lung dampness syndrome often present with: recurrent erythema and papules on the face, neck, limbs, or trunk; some lesions are rough or lichenified; and significant itching. Other symptoms include irritability, poor sleep, restlessness, loss of appetite, and fatigue. Bowel movements may be normal or loose, pale red or pale tongue with a thin white or greasy white coating, and a thready pulse. For this type of patient, CN116459322A discloses a traditional Chinese medicine composition for treating atopic dermatitis, which is composed of the following raw materials by weight: 10-50 parts of Rehmannia glutinosa, 5-30 parts of Dioscorea opposita, 2-8 parts of Ephedra sinica, 10-60 parts of Gypsum fibrosum, 10-30 parts of Poria cocos, 5-30 parts of Paeonia suffruticosa, 5-15 parts of Dictamnus dasycarpus, 5-30 parts of Coix lacryma-jobi, 5-15 parts of Scrophularia ningpoensis, and 5-30 parts of Angelica sinensis. This drug composition takes "nourishing the kidney and strengthening the spleen, clearing heat and relieving itching" as its core treatment principle, and has the effect of quickly reducing skin lesions, relieving itching, and reducing the dosage of glucocorticoids. CN115054662A discloses a traditional Chinese medicine composition for treating skin diseases, targeting the syndrome of water deficiency and excessive fire with stagnation. This composition contains 10-30 parts of Rehmannia glutinosa, 5-25 parts of Gardenia jasminoides, 5-20 parts of Scrophularia ningpoensis, 5-15 parts of Lophatherum gracile, 5-15 parts of chicken gizzard lining, 5-10 parts of Areca catechu, 5-20 parts of Uncaria rhynchophylla, 10-30 parts of Imperata cylindrica, 5-15 parts of Crataegus pinnatifida, 5-15 parts of Lonicera japonica, 5-15 parts of Hordeum vulgare malt, 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, and 5-15 parts of Poria cocos. This composition, based on the core principle of "nourishing the congenital kidney water deficiency, clearing the excess heart fire, and guiding the spleen and stomach stagnation," has the effect of rapidly reducing skin lesions and relieving itching. Summary of the Invention

[0005] Kidney essence deficiency, spleen deficiency with dampness, and lung qi stagnation are important pathogenesis factors that cause atopic dermatitis (AD) with itching. This invention takes "nourishing the kidney and strengthening the spleen, and clearing the lungs and resolving dampness" as its core treatment principle, and provides a Chinese medicine for treating skin diseases that is fast-acting, safe, and has better efficacy. It provides a treatment plan for children or adolescents with spleen and kidney deficiency and lung qi stagnation with dampness.

[0006] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating skin diseases, said traditional Chinese medicine composition being made from the following traditional Chinese medicines in parts by weight:

[0007] The principal ingredient consists of 5-20 parts Rehmannia glutinosa and 5-30 parts Dioscorea opposita;

[0008] The herbal formula consists of 2-10 parts Cornus officinalis, 1-10 parts Ephedra sinica, 5-30 parts Gypsum fibrosum, and 5-20 parts Medicated Leaven;

[0009] The adjuvant drug consists of drug A or drug B, wherein:

[0010] Drug A consists of 2-10 parts of peony bark, 5-20 parts of hawthorn, and 5-20 parts of bitter orange peel;

[0011] Drug B consists of 5-20 parts of Codonopsis pilosula, 5-20 parts of Atractylodes macrocephala, and 5-25 parts of Poria cocos.

[0012] Preferably, the traditional Chinese medicine composition for treating skin diseases is made from the following traditional Chinese medicines in parts by weight:

[0013] The principal ingredient consists of 5-15 parts Rehmannia glutinosa and 5-20 parts Dioscorea opposita;

[0014] The herbal formula consists of 2-8 parts Cornus officinalis, 1-6 parts Ephedra sinica, 5-20 parts Gypsum fibrosum, and 5-15 parts Medicated Leaven;

[0015] The adjuvant drug consists of drug A or drug B, wherein:

[0016] Drug A consists of 2-8 parts of peony bark, 5-15 parts of hawthorn, and 5-15 parts of bitter orange peel;

[0017] Drug B consists of 5-15 parts of Codonopsis pilosula, 5-15 parts of Atractylodes macrocephala, and 5-20 parts of Poria cocos.

[0018] More preferably, the traditional Chinese medicine composition for treating skin diseases is made from the following traditional Chinese medicines in parts by weight:

[0019] The principal ingredient consists of 5-10 parts Rehmannia glutinosa and 5-10 parts Dioscorea opposita;

[0020] The herbal formula consists of 2-6 parts Cornus officinalis, 1-4 parts Ephedra sinica, 5-10 parts Gypsum fibrosum, and 5-10 parts Medicated Leaven.

[0021] The adjuvant drug consists of drug A or drug B, wherein:

[0022] Drug A consists of 2-6 parts of peony bark, 5-10 parts of hawthorn, and 5-10 parts of bitter orange peel;

[0023] Drug B consists of 5-10 parts of Codonopsis pilosula, 5-10 parts of Atractylodes macrocephala, and 5-15 parts of Poria cocos.

[0024] In some specific embodiments of the present invention, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: 5-20 parts of Rehmannia glutinosa, 5-30 parts of Dioscorea opposita, 2-10 parts of Cornus officinalis, 1-10 parts of Ephedra sinica, 5-30 parts of Gypsum fibrosum, 5-20 parts of Massa fermentata, 2-10 parts of Paeonia suffruticosa, 5-20 parts of Crataegus pinnatifida, and 5-20 parts of Citrus aurantium.

[0025] Preferably, in some specific embodiments of the present invention, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: 5-15 parts of Rehmannia glutinosa, 5-20 parts of Dioscorea opposita, 2-8 parts of Cornus officinalis, 1-6 parts of Ephedra sinica, 5-20 parts of Gypsum fibrosum, 5-15 parts of Massa fermentata, 2-8 parts of Paeonia suffruticosa, 5-15 parts of Crataegus pinnatifida, and 5-15 parts of Citrus aurantium.

[0026] More preferably, in some specific embodiments of the present invention, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: 5-10 parts of Rehmannia glutinosa, 5-10 parts of Dioscorea opposita, 2-6 parts of Cornus officinalis, 1-4 parts of Ephedra sinica, 5-10 parts of Gypsum fibrosum, 5-10 parts of Massa fermentata, 2-6 parts of Paeonia suffruticosa, 5-10 parts of Crataegus pinnatifida, and 5-10 parts of Citrus aurantium.

[0027] In some specific embodiments of the present invention, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: 5-20 parts of Rehmannia glutinosa, 5-30 parts of Dioscorea opposita, 2-10 parts of Cornus officinalis, 1-10 parts of Ephedra sinica, 5-30 parts of Gypsum fibrosum, 5-20 parts of Massa fermentata, 5-20 parts of Codonopsis pilosula, 5-20 parts of Atractylodes macrocephala, and 5-25 parts of Poria cocos.

[0028] Preferably, in some specific embodiments of the present invention, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: 5-15 parts of Rehmannia glutinosa, 5-20 parts of Dioscorea opposita, 2-8 parts of Cornus officinalis, 1-6 parts of Ephedra sinica, 5-20 parts of Gypsum fibrosum, 5-15 parts of Massa fermentata, 5-15 parts of Codonopsis pilosula, 5-15 parts of Atractylodes macrocephala, and 5-20 parts of Poria cocos.

[0029] More preferably, in some specific embodiments of the present invention, the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: 5-10 parts of Rehmannia glutinosa, 5-10 parts of Dioscorea opposita, 2-6 parts of Cornus officinalis, 1-4 parts of Ephedra sinica, 5-10 parts of Gypsum fibrosum, 5-10 parts of Massa fermentata, 5-10 parts of Codonopsis pilosula, 5-10 parts of Atractylodes macrocephala, and 5-15 parts of Poria cocos.

[0030] Furthermore, the skin disease includes one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, and / or psoriasis.

[0031] Furthermore, the aforementioned atopic dermatitis includes simple atopic dermatitis and mixed atopic dermatitis.

[0032] Secondly, the present invention provides a traditional Chinese medicine preparation for treating skin diseases, wherein the traditional Chinese medicine preparation contains the traditional Chinese medicine composition described in the first aspect of the present invention and its pharmaceutically acceptable excipients.

[0033] Furthermore, the excipients are pharmaceutical excipients that enhance the efficacy of the active pharmaceutical ingredient, reduce its toxicity, and / or alleviate its side effects.

[0034] Furthermore, the traditional Chinese medicine preparation is one or more of the following: paste, pill, elixir, decoction, granule, capsule, powder and / or tablet.

[0035] Furthermore, the skin disease includes one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, and / or psoriasis.

[0036] Furthermore, the aforementioned atopic dermatitis includes simple atopic dermatitis and mixed atopic dermatitis.

[0037] Thirdly, the present invention provides the application of the traditional Chinese medicine composition described in the first aspect of the present invention and the traditional Chinese medicine preparation described in the second aspect of the present invention in the preparation of a medicament for treating skin diseases.

[0038] Furthermore, the skin disease includes one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, and / or psoriasis.

[0039] Furthermore, the aforementioned atopic dermatitis includes simple atopic dermatitis and mixed atopic dermatitis.

[0040] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows:

[0041] Rehmannia glutinosa: Sweet 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 fluids. It is used for heat entering the blood level, febrile diseases with rashes, hematemesis and epistaxis, yin deficiency due to febrile diseases, thirst and irritability, constipation due to fluid depletion, fever due to yin deficiency, steaming bone fever, and thirst due to internal heat.

[0042] Yam: Sweet and neutral in nature. It enters the spleen, lung, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. It is used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and asthma, kidney deficiency with seminal emission, leukorrhea, frequent urination, and thirst due to deficiency heat. Stir-fried yam with wheat bran tonifies the spleen and stomach. It is used for spleen deficiency with poor appetite, loose stools, and excessive leukorrhea.

[0043] Cornus officinalis: Sour and astringent in taste, slightly warm in nature. It enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys, astringing and consolidating. It is used for dizziness and tinnitus, lower back and knee pain, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and thirst.

[0044] Ephedra: pungent and slightly bitter in taste, warm in nature. It enters the lung and bladder meridians. It has the effects of inducing sweating and dispelling cold, clearing the lungs and relieving asthma, and promoting diuresis and reducing edema. It is used for wind-cold type common cold, chest tightness and cough, and edema due to wind-dampness. Honey-processed ephedra moistens the lungs and relieves cough. It is often used when the exterior syndrome has subsided and there is still cough with wheezing.

[0045] Gypsum: Sweet and pungent in taste, very cold in nature. It enters the lung and stomach meridians. It has the effects of clearing heat and purging fire, relieving irritability and quenching thirst. It is used for exogenous febrile diseases, high fever and thirst, lung heat and cough, excessive stomach fire, headache, and toothache.

[0046] 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.

[0047] Moutan bark: Bitter and pungent in taste, slightly cold in nature. It enters the heart, liver, and kidney meridians. It has the functions of clearing heat and cooling blood, promoting blood circulation and removing blood stasis. It is used for heat entering the blood level, febrile diseases with rashes, hematemesis and epistaxis, night fever and morning coolness, steaming bone fever without sweating, amenorrhea and dysmenorrhea, traumatic injuries, carbuncles and boils.

[0048] 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, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain, and high blood sugar.

[0049] 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.

[0050] Codonopsis pilosula: Sweet and slightly bitter in taste, neutral in nature. It enters the spleen and lung meridians. It has the effects of invigorating qi and strengthening the spleen, promoting body fluid production and moistening the lungs. It is used for spleen deficiency with fatigue, loss of appetite, weakness after illness, qi and yin deficiency, spontaneous sweating and thirst, and dry cough due to lung dryness.

[0051] Atractylodes macrocephala: Bitter and sweet in taste, warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0052] Poria cocos: Sweet and bland in taste, neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, poor appetite due to deficiency, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0053] The treatment principle in this invention:

[0054] Based on the "water and fire in balance" theory of the Book of Changes, this study proposes that kidney essence deficiency is the core factor throughout AD, excessive heart fire is the initiating factor, and gastrointestinal stagnation and spleen dysfunction are important causes. Prolonged disease course or individual differences in constitution, spleen deficiency with dampness accumulation and lung qi stagnation are important pathogenic mechanisms leading to itching in AD. Therefore, an innovative treatment plan of nourishing the kidneys and strengthening the spleen, and clearing the lungs and resolving dampness is proposed.

[0055] In the traditional Chinese medicine composition of this invention, Rehmannia glutinosa and Dioscorea opposita are the principal herbs, which nourish the kidneys and replenish the essence and marrow. Rehmannia glutinosa nourishes the kidneys and replenishes the essence and marrow. Dioscorea opposita strengthens the spleen and replenishes the qi, and can also consolidate the essence. Cornus officinalis, Ephedra sinica, Gypsum fibrosum and Medicated Leaven are the assistant herbs. Cornus officinalis helps Rehmannia glutinosa nourish the liver and kidneys. Medicated Leaven strengthens the spleen and promotes digestion and unblocks the middle jiao. Ephedra sinica promotes lung function and diuresis to resolve dampness and turbidity. Gypsum fibrosum clears heat and stagnation, and when combined with Ephedra sinica, it prevents excessive dispersion of lung qi.

[0056] For those with food stagnation, hawthorn is used to aid digestion and relieve stagnation, bitter orange peel is used to regulate qi and relieve stagnation, peony bark is used to cool the blood and relieve itching, and the warming and astringent properties of cornus officinalis are countered; for those with severe spleen deficiency, codonopsis is used to invigorate qi and strengthen the spleen, generate fluids and moisten the lungs, atractylodes macrocephala and poria cocos are used to strengthen the spleen and eliminate dampness, and yam is used to strengthen the middle jiao.

[0057] Beneficial effects

[0058] 1. The total effective rate of Zishen Jianpi Xuanfei Decoction A formula in this invention is 93.33%, and the total effective rate of formula B formula is 90%, both significantly higher than the 70.00% of the control group; in the treatment of mild and moderate AD patients, it can quickly reduce skin lesions and relieve itching, and shows obvious advantages in controlling recurrence.

[0059] 2. No adverse reactions were observed caused by the traditional Chinese medicine of the present invention during the entire treatment process, indicating that the traditional Chinese medicine composition of the present invention has good safety.

[0060] 3. The kidney-nourishing, spleen-strengthening, and lung-clearing decoction of this invention has significant efficacy in treating atopic dermatitis, has a better taste for children, and is more easily accepted by children, thus having good application prospects in the market. Detailed Implementation

[0061] 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.

[0062] 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.

[0063] Example 1: Traditional Chinese Medicine Composition

[0064] Kidney-Nourishing, Spleen-Strengthening, and Lung-Clearing Decoction Formula A: 10 parts Rehmannia glutinosa, 10 parts Dioscorea opposita, 5 parts Cornus officinalis, 3 parts Ephedra sinica, 8 parts Gypsum fibrosum, 10 parts Massa fermentata, 5 parts Paeonia suffruticosa, 10 parts Crataegus pinnatifida, and 10 parts Citrus aurantium.

[0065] Kidney-Nourishing, Spleen-Strengthening, and Lung-Clearing Decoction (Formula B): 10 parts Rehmannia glutinosa, 10 parts Dioscorea opposita, 5 parts Cornus officinalis, 3 parts Ephedra sinica, 8 parts Gypsum fibrosum, 10 parts Massa fermentata, 10 parts Codonopsis pilosula, 10 parts Atractylodes macrocephala, and 13 parts Poria cocos.

[0066] Preparation method: Put the above-mentioned medicinal materials into a pot, add 8 times the amount of water and soak for 30 minutes. Boil for 25 minutes the first time, add 6 times the amount of water and boil for 25 minutes the second time. Combine the decoctions, concentrate and filter to 400ml (for children, it can be concentrated to 150-200ml).

[0067] Example 2 Clinical Data

[0068] 1. Research Methods

[0069] 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 (atopic dermatitis) patients with spleen and kidney deficiency and lung dampness syndrome.

[0070] 2 Design Scheme

[0071] 2.1 Research Subjects

[0072] This study selected patients with atopic dermatitis (Siwanfeng) and spleen-kidney deficiency and lung dampness 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.

[0073] 2.2 Diagnostic criteria

[0074] 2.2.1 Western Medicine Diagnostic Criteria

[0075] 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".

[0076] The severity of atopic dermatitis was assessed using the Scoring for Atopic Dermatitis (SCORAD) score: mild (SCORAD score 0-24), moderate (SCORAD score 25-50), and severe (SCORAD score >50).

[0077] 2.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0078] Based on references to "Zhang Zhili, a Doctor of Excellent Medical Skills," "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 "Standards for Diagnosis and Efficacy Evaluation of Diseases in Traditional Chinese Medicine" (National Standard of Traditional Chinese Medicine Industry), the following guidelines were drafted:

[0079] Spleen and kidney deficiency with lung dampness accumulation:

[0080] Recurrent erythema and papules on the face, neck, limbs, or trunk; some lesions are rough or lichenified; significant itching. Irritability, poor sleep, restlessness, loss of appetite, or fatigue may be present; normal or loose stools; pale red or pale tongue with a thin white or greasy white coating; thready pulse.

[0081] 2.2.3 Inclusion Criteria

[0082] ① Meets the above-mentioned Western medicine clinical diagnostic criteria for mild to moderate atopic dermatitis;

[0083] ② It meets the diagnostic criteria for spleen and kidney deficiency and lung stagnation with dampness;

[0084] ③ Age 2-18 years old, gender not limited;

[0085] ④ Good compliance; able to cooperate with the collection of clinical data;

[0086] ⑤ No systemic use of hormones, antihistamines, or immunosuppressants in the past two weeks;

[0087] ⑥ No systematic use of biological agents or small molecule targeted drugs within 4 weeks;

[0088] ⑦ The individual or their guardian must obtain permission to 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.

[0089] Those who meet all of the above conditions are eligible for inclusion and will be included in this study.

[0090] 2.2.4 Exclusion Criteria

[0091] ① Patients with any other skin diseases that may interfere with the evaluation of test results;

[0092] 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;

[0093] ③ Patients with concurrent severe skin or systemic infections;

[0094] ④ Patients with a history of allergy to any component of the research drug;

[0095] ⑤ Patients who cannot receive traditional Chinese medicine decoction treatment;

[0096] ⑥ Patients who are participating in other drug clinical trials.

[0097] If any of the above criteria are met, the patient will be excluded and not included in this study.

[0098] 2.2.5 Exclusion Criteria

[0099] ① Those who were mistakenly included but did not meet the inclusion criteria;

[0100] ②Those who use other drugs or treatment plans during the treatment process, affecting the assessment of efficacy.

[0101] 2.2.6 Shedding Criteria

[0102] ①Those who entered the trial treatment but ultimately did not complete the clinical observation;

[0103] ②Those who did not have regular follow-up visits during treatment and were lost to follow-up for various reasons during the follow-up period;

[0104] ③ Those who are unwilling to continue clinical trials during the treatment process.

[0105] 2.2.7 Standard for Complete Suspension

[0106] ① Those who experience serious adverse reactions or allergic reactions during clinical trials;

[0107] 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;

[0108] ③ Researchers consider the necessity of terminating the trial from a medical perspective.

[0109] 2.3 Clinical Research Protocol

[0110] 2.3.1 Treatment Groups

[0111] The subjects were divided into experimental group 1, experimental group 2 and control group.

[0112] 2.3.2 Randomization Scheme

[0113] 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.

[0114] 2.3.3 Sampling Method

[0115] The enrolled cases were randomly assigned to the experimental group and the control group in a 1:1:1 ratio.

[0116] 2.3.4 Sample Size

[0117] This study was an exploratory study. Based on clinical experience and considering a clinical dropout rate of 10%, the total number of cases in the trial was 99 (experimental group 1: 33 cases, experimental group 2: 33 cases, control group: 33 cases).

[0118] 2.3.5 Treatment methods

[0119] Experimental group 1:

[0120] Oral medication: Take the Kidney-Nourishing, Spleen-Strengthening, and Lung-Clearing Decoction (Formula A). Put the herbs into a pot, add 8 times the amount of water and soak for 30 minutes. Boil for 25 minutes the first time, and add 6 times the amount of water the second time and boil for 25 minutes. Combine the decoctions, concentrate and filter to 400ml (for children, concentrate to 150-200ml). Divide into two doses and take orally, half an hour after meals, once in the morning and once in the evening.

[0121] Topical medication: Apply 0.1% mometasone furoate cream (Elosone cream, Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) once daily. Avoid applying the medication to the face, neck, and body folds.

[0122] Experimental Group 2: Patients with fatigue, loss of appetite, and loose stools were included in Experimental Group 2.

[0123] Oral medication: Take the Kidney-Nourishing, Spleen-Strengthening, and Lung-Clearing Decoction (Formula B) orally. Put the herbs into a pot, add 8 times the amount of water and soak for 30 minutes. Boil for 25 minutes the first time, and add 6 times the amount of water the second time and boil for 25 minutes. Combine the decoctions, concentrate and filter to 400ml (for children, concentrate to 150-200ml). Divide into two doses and take orally, half an hour after meals, once in the morning and once in the evening.

[0124] Topical medication: Apply 0.1% mometasone furoate cream (Elosone cream, Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) once daily. Avoid applying the medication to the face, neck, and body folds.

[0125] Control group:

[0126] Topical medication: Apply 0.1% mometasone furoate cream (Elosone cream, Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval Number H19991418) once daily. Avoid applying the medication to the face, neck, and body folds.

[0127] Treatment duration: 4 weeks. Patients will return for follow-up visits every week to record the degree of improvement in their condition. Health education will be provided to the three 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.

[0128] Remedial measures: If the itching is unbearable in the experimental group, temporary topical application of Eloson cream is permitted. Record the application time.

[0129] 2.3.6 Blinding

[0130] 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.

[0131] 2.3.7 Evaluation of therapeutic effect

[0132] ① Primary efficacy endpoint – SCORAD score

[0133] 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):

[0134] A. Calculation of lesion extent: Anterior body: head 4.5%, trunk 18%, upper limbs (unilateral) 4.5%, lower limbs (unilateral) 9%; posterior body is calculated using the same method as the anterior body; additionally, the vulva is counted at 1%, for a total score of 100 points. (See Appendix 1 for details)

[0135] B. Severity of skin lesions: The severity of skin lesions is divided into four levels: none, mild, moderate, and severe, using a score of 0-3 for estimation. This is mainly assessed by evaluating erythema, papules / edema, crusting, lichenification / thickening, epidermal peeling at the lesion site, and dryness of the skin in non-lesion areas.

[0136] 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.

[0137] The formula for calculating the SCORAD score is: A / 5 + 7B / 2 + C.

[0138] Table 1 SCORAD Rating Assessment Scale

[0139]

[0140]

[0141] ② Research evaluation indicators

[0142] 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.

[0143] 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.

[0144] 2.4 Efficacy Evaluation Criteria

[0145] 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).

[0146] The calculation formula (nimodipine method) is: Efficacy index = [(pre-treatment SCORAD total score - post-treatment SCORAD total score) / pre-treatment SCORAD total score] × 100%.

[0147] Therapeutic effect evaluation:

[0148] Clinical cure: the rash has basically subsided, the symptoms have disappeared, and the efficacy rate is ≥90%;

[0149] Significant effect: Most of the rash subsided, and symptoms were significantly improved; efficacy rate ≤ 60% < 90%;

[0150] Effective: The rash partially subsided, and the symptoms improved; the efficacy rate was 20% ≤ efficacy rate < 60%.

[0151] Ineffective: The rash does not subside significantly, the symptoms do not improve or even worsen, and the efficacy rate is <20%;

[0152] Overall effective rate = [(number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases] × 100%.

[0153] 2.5 Research Summary

[0154] 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, underwent statistical analysis of the efficacy data based on the protocol compliance dataset.

[0155] 2.6 Statistical Analysis and Content

[0156] Statistical analysis will be performed using SPSS 22.0 statistical analysis software. All inter-group 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 categorical 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's correlation test will be used for correlation analysis.

[0157] 3. Research Results

[0158] 3.1 Case Data

[0159] Cases were collected from patients visiting the Dermatology Outpatient Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between February 2023 and March 2024. After the Patient Case Report Form (CRF) was completed, two different data entry personnel entered and verified the data twice. A total of 99 patients were enrolled, with 8 dropping out due to personal reasons, resulting in 91 cases ultimately included in the statistical analysis. The experimental group consisted of 30 patients in group 1, 31 patients in group 2, and 30 patients in the control group.

[0160] 3.2 Baseline Data

[0161] Of the 91 patients, 46 were male and 45 were female, with a mean age of 8.76 ± 3.91 years and a mean disease duration of 5.30 ± 3.83 months. Before treatment, the gender of the experimental and control groups was determined by a chi-square test. The age and disease duration of the patients in the three groups were all normally distributed with homogeneous variances. An independent samples t-test indicated no significant difference between the two groups.

[0162] 3.3 Evaluation of therapeutic effect

[0163] 3.3.1 SCORAD Score

[0164] Comparing the total SCORAD scores before and after treatment, paired t-tests showed no significant difference between the experimental and control groups before treatment. After treatment, the total SCORAD scores of both groups decreased significantly (P<0.05), with a more pronounced decrease in the experimental group (P<0.001). There was no significant difference between experimental group 1 and experimental group 2 (P>0.05), but a statistically significant difference in SCORAD scores between the experimental and control groups (P<0.05), suggesting that the treatment group experienced more significant remission after 4 weeks. See Table 2.

[0165] Table 2. Comparison of SCORAD scores before and after treatment

[0166]

[0167] 3.3.2 Overall efficacy evaluation

[0168] The SCORAD index of the two treatment groups was divided into four levels: cured, significantly effective, effective, and ineffective, and analyzed using the chi-square test. In experimental group 1, the total number of effective cases was 28, with a total effective rate of 93.33%; in experimental group 2, the total number of effective cases was 27, with a total effective rate of 90.00%; and in the control group, the total number of effective cases was 21, with a total effective rate of 70.00%. There was no significant difference between experimental groups 1 and 2 (P > 0.05); however, both experimental groups 1 and 2 showed significant differences compared to the control group (P < 0.05). This indicates that the efficacy of experimental groups 1 and 2 was superior to that of the control group, and the differences in efficacy between the groups were statistically significant.

[0169] 3.3.2 Comparison of relapse rates between the two groups of children

[0170] One month after the end of treatment, a follow-up study revealed that 5 children in experimental group 1, 4 children in experimental group 2, and 12 children in the control group relapsed. The relapse rate between the two groups was compared with the corrected chi-square test. There was no significant difference between experimental group 1 and experimental group 2 (P>0.05). The differences between experimental group 1 and experimental group 2 and the control group were statistically significant (P<0.05).

[0171] 3.4 Adverse Reactions

[0172] No adverse reactions were observed in experimental group 1, experimental group 2, or the control group.

Claims

1. A traditional Chinese medicine composition for treating atopic dermatitis due to spleen and kidney deficiency and lung dampness, said traditional Chinese medicine composition being made from the following traditional Chinese medicines in parts by weight: The principal ingredient consists of 5-10 parts Rehmannia glutinosa and 5-10 parts Dioscorea opposita; The herbal formula consists of 2-6 parts Cornus officinalis, 1-4 parts Ephedra sinica, 5-10 parts Gypsum fibrosum, and 5-10 parts Medicated Leaven. The adjuvant drug consists of drug A or drug B, wherein: Drug A consists of 2-6 parts of peony bark, 5-10 parts of hawthorn, and 5-10 parts of bitter orange peel; Drug B consists of 5-10 parts of Codonopsis pilosula, 5-10 parts of Atractylodes macrocephala, and 5-15 parts of Poria cocos.

2. A traditional Chinese medicine preparation for treating skin diseases, said traditional Chinese medicine preparation being made from the traditional Chinese medicine composition of claim 1 and its pharmaceutically acceptable excipients.

3. In the traditional Chinese medicine preparation as described in claim 2, the excipients are pharmaceutical excipients that enhance the efficacy, reduce toxicity, and / or alleviate the side effects of the main drug.

4. The traditional Chinese medicine preparation as described in claim 2, wherein the traditional Chinese medicine preparation is one or more of the following: paste, pill, elixir, decoction, granule, capsule, powder and / or tablet.

5. The use of the traditional Chinese medicine composition as described in claim 1 or the traditional Chinese medicine preparation as described in claim 2 in the preparation of a drug for treating atopic dermatitis caused by spleen and kidney deficiency and lung dampness accumulation.

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