Traditional Chinese medicine composition for promoting growth and development of spleen-kidney deficiency type short children and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for promoting growth and development of spleen-kidney deficiency type short children and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 3 parts of pseudo-ginseng, 9 parts of cinnamon, 10 parts of raw hawthorn, 10 parts of ramulus mori, 10 parts of radix salviae miltiorrhizae, 10 parts of rhizoma corydalis, 9 parts of herba epimedii, 9 parts of rhizoma drynariae and 9 parts of radix dipsaci. The traditional Chinese medicine composition disclosed by the invention recovers the fundamental pathogenesis of spleen-kidney deficiency and promotes the growth and development of children through comprehensive conditioning of warming yang and tonifying kidney, tonifying qi and strengthening body and promoting blood circulation to remove blood stasis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition and its application for promoting the growth and development of children with short stature due to spleen and kidney deficiency. Background Technology

[0002] Children's growth and development is an important comprehensive indicator reflecting socioeconomic development, cultural and educational status, and nutritional and health care levels. Currently, people pay far less attention to children with short stature than to those with growth hormone deficiency and idiopathic dwarfism. However, short stature inevitably has varying degrees of negative impact on children's psychological development, behavioral formation, and their life, employment, and mental well-being in adulthood. Short stature is defined as a child's height being one to two standard deviations (or the 25th percentile) below the average height of children of the same age, race, and sex, excluding known causes such as congenital nutritional malabsorption disorders, endocrine disorders, skeletal diseases, chronic systemic diseases, and those with serious complications. Except for children whose height does not meet the diagnostic criteria for dwarfism, other cases resemble idiopathic dwarfism. If not corrected in time, short stature can further develop into dwarfism, leading not only to increased medical costs and a heavier financial burden on families, but also potentially impairing the child's adult height. Therefore, to promote children's healthy physical and mental development, we need to be more proactive in preventing and treating short stature.

[0003] Studies have found that the growth hormone-insulin-like growth factor 1 (GH-IGF-1) axis is the most important regulatory axis for linear growth in humans, playing a decisive role in children's physical growth. Most functions of growth hormone (GH) are mediated by insulin-like growth factor 1 (IGF-1), thus exerting a powerful effect on promoting linear growth. GH first binds to the peripheral growth hormone receptor (GHR), promoting the synthesis and release of IGF-1 in the liver. IGF-1 is a growth-promoting polypeptide that directly acts on chondrocytes to stimulate their proliferation and differentiation, regulating longitudinal growth in children. In the bloodstream, extracellular space, and various tissues, IGF-1 mainly exists in protein-bound form (IGFBPs), with IGFBP3 being the predominant form (over 95%). IGFBP3 acts as a transport and storage protein for IGF1, responsible for releasing IGF1 into the bloodstream to exert its biological activity.

[0004] Numerous factors influence growth and development, including genetic factors and diseases, diet, family food resources, childcare, health services, and environmental, economic, social policies, and educational factors. Genetics determines growth potential, while environmental factors regulate innate potential, resulting in different individual growth patterns. Western medicine, both domestically and internationally, does not yet pay sufficient attention to this condition, lacking unified treatment guidelines or consensus and effective drug treatment experience. Treatment focuses primarily on etiological analysis and comprehensive intervention, mainly involving comprehensive intervention and symptomatic treatment such as eliminating the cause, adjusting diet, promoting digestion, and preventing complications. Treatment methods are limited, and mild cases are easily overlooked, lacking effective treatment options. Clinically, indicators commonly used to evaluate children's growth and development include height, weight, body mass index (BMI), and bone age. Bone age measurement can predict a child's final adult height, reflecting the maturity of physical development—essentially reflecting changes in tissue biochemical composition. Evaluating children's growth and development based on bone age levels provides a more accurate and realistic reflection of an individual's overall developmental level than height and weight.

[0005] Traditional Chinese medicine lacks a specific discussion of this condition; terms like "five delays," "fetal weakness," and "asthenia" do not fully describe it. Due to the physiological and pathological characteristics of children, such as "frequent spleen deficiency and kidney deficiency," short stature often results from insufficient fetal essence, congenital kidney qi deficiency, and kidney essence depletion, impairing the kidney's function of governing bones and marrow. If the spleen and stomach are weak later in life, coupled with improper diet and feeding, the spleen and stomach fail to transform nutrients, leading to insufficient nourishment of the five internal organs and affecting growth and development. This view is confirmed in investigations into the causes of short stature. Studies have found that nutritional short stature accounts for 47.87% of common causes in Chinese children, mostly due to long-term poor eating habits such as picky eating and anorexia, or chronic digestive diseases, leading to a lack of nutrients needed for growth, poor immune function, and consequently affecting children's growth and development. Furthermore, proper dietary nutrition absorption is related to the secretion and function of IGF-1, which is related to height growth, in children's bodies. Simultaneously, the lack of nourishment from the spleen and stomach's acquired essence of food and water in the kidneys also affects the kidneys' physiological function of governing growth and development. Furthermore, the healthy functioning of the spleen depends on the warming and transforming function of kidney yang; kidney deficiency leads to impaired spleen function and insufficient production of essence. Pan Danping et al. have confirmed that bone growth is the result of the combined action of congenital kidney essence and acquired spleen function. Traditional Chinese medicine for strengthening the spleen and tonifying the kidneys can promote the body's absorption of organic and inorganic substances, which is beneficial for bone formation and accelerates bone growth. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition and its application for promoting the growth and development of children with short stature due to spleen and kidney deficiency. It has the effects of "tonifying qi and warming yang, activating blood and nourishing the kidney". At the same time, it focuses on the transdermal properties of the ointment, and adds a transdermal agent of Western medicine. The ointment has a light and moisturizing texture, which is conducive to transdermal absorption. It aims to achieve the purpose of "regulating the internal organs and balancing yin and yang", improving the height of children with short stature, while also paying attention to the impact on children's bone age and sexual development.

[0007] To achieve the above-mentioned technical objectives and effects, the present invention is implemented through the following technical solution:

[0008] A traditional Chinese medicine composition for promoting growth and development in children with short stature due to spleen and kidney deficiency includes: Panax notoginseng, cinnamon, hawthorn, mulberry twig, Salvia miltiorrhiza, Corydalis yanhusuo, Epimedium, Drynaria fortunei, and Dipsacus asper.

[0009] Furthermore, the raw materials of the traditional Chinese medicine composition are proportioned as follows: Panax notoginseng 1-5 parts, cinnamon 6-12 parts, hawthorn 7-13 parts, mulberry twig 7-13 parts, Salvia miltiorrhiza 7-13 parts, Corydalis yanhusuo 7-13 parts, Epimedium 6-12 parts, Drynaria fortunei 6-12 parts, and Dipsacus asper 6-12 parts.

[0010] Furthermore, the raw materials of the traditional Chinese medicine composition are in the following weight proportions: Panax notoginseng 3 parts, cinnamon 9 parts, hawthorn 10 parts, mulberry twig 10 parts, Salvia miltiorrhiza 10 parts, Corydalis yanhusuo 10 parts, Epimedium 9 parts, Drynaria fortunei 9 parts, and Dipsacus asper 9 parts.

[0011] On the other hand, the present invention proposes a traditional Chinese medicine product for promoting the growth and development of children with short stature due to spleen and kidney deficiency. The traditional Chinese medicine product is an external application prepared from the above-mentioned traditional Chinese medicine formula.

[0012] Furthermore, the external application agents include, but are not limited to, decoctions, tinctures, ointments, and oils.

[0013] Furthermore, the external application preparation consists of 3g of Panax notoginseng, 9g of cinnamon, 10g of hawthorn, 10g of mulberry twig, 10g of Salvia miltiorrhiza, 10g of Corydalis yanhusuo, 9g of Epimedium, 9g of Drynaria fortunei, and 9g of Dipsacus asper. After the above herbs are decocted and concentrated, 20g of triethanolamine, 100g of glycerin, 120g of stearic acid, and 200g of petrolatum are added to each 560g serving of the decoction. Each 1ml of the decoction is equivalent to 1g of Chinese herbal medicine slices. One batch yields 1000g of finished product, and each box contains 30g of ointment medium for later use.

[0014] On the other hand, the present invention proposes the application of the above-mentioned traditional Chinese medicine composition as a drug for promoting the growth and development of children with short stature due to spleen and kidney deficiency.

[0015] Panax notoginseng: Properties: sweet and slightly bitter, warm; enters the liver and stomach meridians; main functions: stops bleeding, disperses blood stasis, reduces swelling, and relieves pain. Treats hematemesis, hemoptysis, epistaxis, hematochezia, bloody dysentery, metrorrhagia, abdominal masses, postpartum hemorrhage, lochia retention, traumatic bleeding, external bleeding, and carbuncles and boils with pain.

[0016] Cinnamon: Properties: pungent, sweet, and hot; enters the kidney, spleen, heart, and liver meridians; main functions: tonifies primordial yang, warms the spleen and stomach, dispels accumulated cold, and unblocks blood vessels. Treats deficiency of kidney yang, cold limbs and weak pulse, collapse of yang, abdominal pain and diarrhea, cold hernia, lower back and knee pain, amenorrhea, abdominal masses, yin carbuncles, phlegm, and floating of deficient yang with upper heat and lower cold.

[0017] Hawthorn: Properties: Sour and sweet, slightly warm; enters the spleen, stomach, and liver meridians; Main uses: aids digestion, promotes qi circulation, dispels blood stasis, and expels tapeworms. Treats indigestion, abdominal masses, phlegm retention, acid reflux, intestinal bleeding, lower back pain, lochia retention, infantile food stagnation, abdominal distension, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, hernia pain, and hyperlipidemia. Raw hawthorn is used to aid digestion and dispel blood stasis, while charred hawthorn is used to stop diarrhea and dysentery.

[0018] Mulberry twigs: Properties: Slightly bitter, neutral; enters the liver meridian. Indications: Dispels wind and dampness, benefits joints, promotes urination. Treats wind-cold-dampness arthralgia, limb contractures, beriberi edema, and wind-induced itching.

[0019] Salvia miltiorrhiza: Properties: Bitter, slightly cold; Meridians: Heart, Pericardium, Liver. Indications: Removes blood stasis and relieves pain, invigorates blood circulation and regulates menstruation, clears the heart and relieves irritability. Treats angina pectoris, irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia, leukorrhea, abdominal masses, accumulations, abdominal pain due to blood stasis, joint pain, palpitations and insomnia, malignant sores and carbuncles.

[0020] Corydalis Rhizome: Properties: Bitter and pungent, warm; enters the heart, liver, and spleen meridians. Indications: invigorates blood circulation, disperses blood stasis, regulates qi, and relieves pain. Treats various pains in the heart, abdomen, waist, and knees; irregular menstruation; abdominal masses; metrorrhagia; postpartum hemorrhage; lochia retention; and traumatic injuries.

[0021] Epimedium: Properties: pungent, sweet, warm; enters the liver and kidney meridians; main functions: tonifies the kidneys and strengthens yang, dispels wind and dampness. Treats impotence, dribbling urination, muscle spasms, hemiplegia, weakness of the lower back and knees, rheumatic pain, and numbness of the limbs.

[0022] Dipsacus asper: Properties: Bitter, sweet, pungent, slightly warm; enters the liver and kidney meridians. Indications: Tonifies the liver and kidneys, promotes bone and tendon healing, regulates blood circulation, heals fractures, and stops metrorrhagia. Treats lower back pain, weakness in the legs and knees, threatened abortion, metrorrhagia, leukorrhea, seminal emission, traumatic injuries, wounds, hemorrhoids, carbuncles, and boils. Wine-processed Dipsacus asper is often used for rheumatic pain and traumatic injuries. Salt-processed Dipsacus asper is often used for lower back and knee weakness.

[0023] Drynaria fortunei: Properties: bitter; warm; enters the liver and kidney meridians; main functions: tonifies the kidneys and strengthens bones, invigorates blood and relieves pain. Treats chronic diarrhea due to kidney deficiency, lower back pain, rheumatic pain, toothache, tinnitus, sprains and strains, bone injuries, appendicitis, alopecia areata, and corns.

[0024] The beneficial effects of this invention are:

[0025] In this invention, cinnamon is the principal ingredient, which is pungent, sweet, and very hot in nature. It enters the kidney, spleen, heart, and liver meridians, and has the functions of warming and tonifying kidney yang, guiding fire back to its source, and warming spleen earth to aid digestion. The kidney is the foundation of innate constitution, and warming and tonifying kidney yang helps promote bone growth and improve bodily functions. The spleen is the foundation of acquired constitution and the source of qi and blood production. Warming spleen yang enhances the body's qi transformation function. Together with the assistant ingredients, they promote children's growth and development and resolve nutrient absorption disorders caused by spleen and kidney yang deficiency.

[0026] Drynaria fortunei, Dipsacus asper, and Epimedium (also known as Epimedium brevicornu) are all used as assistant herbs. Drynaria fortunei, bitter and warm in nature, enters the liver and kidney meridians. It tonifies the kidneys and strengthens bones, promotes healing and relieves pain, and promotes bone growth and repair. It directly promotes normal bone development in children. When combined with Dipsacus asper, it synergistically strengthens the kidneys and bones. Dipsacus asper, bitter, pungent, and slightly warm in nature, enters the liver and kidney meridians. It tonifies the liver and kidneys, strengthens tendons and bones, and heals fractures. Combined with Drynaria fortunei, it enhances the kidney-tonifying and bone-strengthening effects, improving the kidney's function of governing bones. Both enter the liver and kidney meridians and tonify the liver and kidneys, promoting tendon and bone healing, especially strengthening bone repair and growth. It is warm and nourishing without being overly drying, suitable for children's "immature yin and yang" constitution. Epimedium (also known as Epimedium brevicornu), pungent, sweet, and warm in nature, enters the liver and kidney meridians. It tonifies the kidneys and strengthens yang, dispels wind and dampness. It warms and tonifies kidney yang to replenish the innate essence, and stimulates kidney qi to aid growth and development. Modern research shows that it can regulate the secretion of growth hormone.

[0027] Danshen, Panax notoginseng, and Corydalis yanhusuo are used as adjuvant herbs to invigorate blood and remove blood stasis. The three herbs work synergistically to improve blood circulation and promote the transport of essential nutrients throughout the body, thereby creating a better internal environment for growth and development. Danshen, bitter and slightly cold, enters the heart and liver meridians. It invigorates blood, removes blood stasis, relieves pain, clears the heart, and relieves irritability, promoting local microcirculation in the bones. Panax notoginseng is good at stopping bleeding without leaving blood stasis, and has the effects of dispersing blood stasis, reducing swelling, and relieving pain. It works synergistically with Danshen, both promoting blood circulation and restraining the excessive potency of blood-invigorating herbs, protecting the child's blood and qi. Corydalis yanhusuo is pungent and warm, harmonizing qi and blood, clearing the meridians, relieving abdominal pain or growing pains that may be accompanied by spleen and kidney deficiency, and synergistically exerting the effects of "tonifying the kidney, warming yang, and invigorating blood," promoting the absorption and utilization of the medicine.

[0028] The ingredients, mulberry twigs and raw hawthorn, harmonize the effects of the other herbs. Mulberry twigs are slightly bitter and neutral, specifically entering the liver meridian. They excel at dispelling wind and dampness, benefiting joints, and clearing the meridians. They also prevent the warming herbs from being too drying, and guide the herbs upwards to reach the limbs, ensuring the medicinal effects are distributed throughout the body and enhancing the overall efficacy. Raw hawthorn is sour, sweet, and slightly warm. It not only aids digestion and strengthens the stomach, but also promotes qi circulation and dispels blood stasis, enhancing the spleen and stomach's digestive function, addressing spleen deficiency and poor appetite, and strengthening the body's foundation.

[0029] In summary, this formula harmonizes both the spleen and kidneys, aligning with the theory of "mutual support between innate and acquired constitutions." It combines activity and rest, balancing blood circulation with tonification to promote a balance between qi and blood circulation and bone growth. It is warming without being drying, making it suitable for children with immature yin and yang constitutions. The careful combination of herbs not only focuses on improving the primary pathogenesis but also achieves a good balancing effect on the overall harmony of the formula, thus realizing its comprehensive therapeutic effect of "regulating the internal organs and harmonizing yin and yang."

[0030] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Detailed Implementation

[0031] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] Example 1

[0033] The traditional Chinese medicine composition described in this embodiment for promoting the growth and development of children with short stature due to spleen and kidney deficiency includes: Panax notoginseng, cinnamon, hawthorn, mulberry twig, Salvia miltiorrhiza, Corydalis yanhusuo, Epimedium, Drynaria fortunei, and Dipsacus asper.

[0034] On the other hand, the present invention proposes a traditional Chinese medicine product for promoting the growth and development of children with short stature due to spleen and kidney deficiency. The traditional Chinese medicine product is an external application prepared from the above-mentioned traditional Chinese medicine formula.

[0035] In this embodiment, the external application agent includes, but is not limited to, decoctions, tinctures, ointments, and oils.

[0036] On the other hand, the present invention proposes the application of the above-mentioned traditional Chinese medicine composition as a drug for promoting the growth and development of children with short stature due to spleen and kidney deficiency.

[0037] Example 2

[0038] The traditional Chinese medicine composition for promoting growth and development in children with short stature due to spleen and kidney deficiency described in this embodiment comprises the following raw materials in the following weight ratios: Panax notoginseng 1-5 parts, cinnamon 6-12 parts, hawthorn 7-13 parts, mulberry twig 7-13 parts, Salvia miltiorrhiza 7-13 parts, Corydalis yanhusuo 7-13 parts, Epimedium 6-12 parts, Drynaria fortunei 6-12 parts, and Dipsacus asper 6-12 parts.

[0039] Example 3

[0040] For children who are physically weak and are significantly shorter than average, it is necessary to enhance the effects of medications that tonify the kidneys, strengthen yang, and fortify muscles and bones.

[0041] The traditional Chinese medicine composition for promoting growth and development in children with short stature due to spleen and kidney deficiency described in this embodiment includes the following raw material weight ratios: 12 parts Epimedium, 12 parts Dipsacus asper, 12 parts Drynaria fortunei, 12 parts Cinnamomum cassia, 8 parts Salvia miltiorrhiza, 3 parts Panax notoginseng, 8 parts Corydalis yanhusuo, 10 parts Morus alba twigs, and 10 parts Crataegus pinnatifida.

[0042] Increase the dosage of Epimedium and Dipsacus: Both Epimedium and Dipsacus have the effects of tonifying the kidneys and strengthening yang, as well as strengthening muscles and bones. Increasing the dosage can more effectively warm and tonify kidney qi and promote bone development. It helps to improve growth retardation caused by kidney deficiency and enhance physical strength and immunity.

[0043] Reduce the dosage of Danshen and Sanqi: These patients may have a relatively low need for promoting blood circulation and removing blood stasis, so reducing the dosage can avoid affecting the effects of other tonifying drugs. This prevents excessive blood circulation from depleting vital energy and maintains the overall tonifying effect.

[0044] Example 4

[0045] For children with average physical condition who need to maintain and promote growth and development, the proportion of medicinal materials should be balanced, taking into account various needs.

[0046] The traditional Chinese medicine composition for promoting growth and development in children with short stature due to spleen and kidney deficiency described in this embodiment comprises the following raw materials in the following weight proportions: Epimedium 8 parts, Dipsacus asper 8 parts, Drynaria fortunei 8 parts, Cinnamomum cassia 8 parts, Salvia miltiorrhiza 9 parts, Panax notoginseng 3 parts, Corydalis yanhusuo 9 parts, Morus alba 7 parts, and Crataegus pinnatifida 9 parts.

[0047] Balance the dosage of tonifying herbs such as Epimedium, Dipsacus, Drynaria, and Cinnamon: maintain a balanced dosage of each herb to ensure a gentle overall tonifying effect. Appropriately increase the dosage of Salvia miltiorrhiza and Corydalis: moderately promote blood circulation and enhance the body's defense capabilities.

[0048] Example 5

[0049] For children with blood stasis, qi stagnation, growing pains, or abdominal pain, it is necessary to strengthen the effects of promoting blood circulation, removing blood stasis, regulating qi, and relieving pain.

[0050] The traditional Chinese medicine composition for promoting growth and development in children with short stature due to spleen and kidney deficiency described in this embodiment comprises the following raw materials in the following weight proportions: Epimedium 10 parts, Dipsacus asper 10 parts, Drynaria fortunei 6 parts, Cinnamomum cassia 10 parts, Salvia miltiorrhiza 13 parts, Panax notoginseng 5 parts, Corydalis yanhusuo 13 parts, Morus alba twig 10 parts, and Crataegus pinnatifida 10 parts.

[0051] Increase the dosage of Danshen and Yanhusuo: Increase the use of drugs that promote blood circulation, remove blood stasis, regulate qi, and relieve pain to alleviate qi stagnation and blood stasis. Improve blood circulation, relieve fatigue, and reduce limb pain. Reduce the dosage of Gusuibu to avoid excessive tonification that could burden the liver and spleen. Prevent the use of greasy and dampness-inducing herbs, especially in individuals with blood stasis constitution, to avoid aggravating qi stagnation.

[0052] Example 6

[0053] The case data were all children who visited the Growth and Development Department of our hospital (Hangzhou Red Cross Hospital) for two consecutive years from March 2022 to May 2025. 160 children who met the inclusion criteria were selected and randomly divided into an experimental group (n=120) and a control group (n=40) with a male-to-female ratio of 1:1.

[0054] Diagnostic criteria

[0055] (1) Western medicine diagnostic criteria: Based on Pediatrics (9th edition) and clinical observation, the following criteria for children with short stature are proposed: height is one standard deviation (or the 25th percentile) to two standard deviations (or the 3rd percentile) below the average height of normal children of the same age, race and sex. At birth, height and weight are within the normal range, the child has a normal body shape, and there are no chromosomal abnormalities or systemic, endocrine or various chronic diseases; the difference between bone age and actual bone age is no more than 1 year; the growth hormone stimulation test results are normal, and the GH peak value is >10ug / L.

[0056] (2) Traditional Chinese Medicine (TCM) diagnostic criteria: Combining the symptoms of pediatric diseases such as fetal weakness, five delays, five weaknesses, and anorexia, and referring to the symptoms of the "five delays" in "Traditional Chinese Medicine Pediatrics" and "Practical Traditional Chinese Medicine Pediatrics," the clinical manifestations of short stature in children with spleen and kidney deficiency are summarized. Primary symptom: Slow growth (in similar living environments, the height of individuals of the same race, sex, and age is between one standard deviation (or the 25th percentile) and two standard deviations (or the 3rd percentile) of the average height of the normal population). Secondary symptoms: Thin physique, reduced appetite, sallow complexion, sparse yellow hair, irregular bowel movements, soft muscles, pale tongue with a thin white coating, or a thin white and smooth coating, deep, slow, and weak pulse, or pale finger veins. If a child possesses one primary symptom and two or more secondary symptoms, and the tongue and pulse examination findings are as described above, they can be diagnosed with spleen and kidney deficiency.

[0057] Case inclusion criteria

[0058] (1) Inclusion criteria: ① Height is within -2SD to -1SD for the same race, sex and age; ② Traditional Chinese medicine diagnosis conforms to the spleen and kidney deficiency type; ③ Age range is 3 to 7 years old, gender is not limited, but there is no development of secondary sexual characteristics and has not yet entered puberty; ④ No growth hormone, A1, protein anabolic hormone, IGF-1 or other drugs have been used to treat this disease; ⑤ The guardian is aware of the child's condition and treatment and gives consent, and is not in other clinical trials, and has signed an informed consent form.

[0059] (2) Exclusion criteria: ① Severe allergic constitution, and / or allergic to the Chinese herbal growth paste; ② Those who have participated in clinical observation of other drugs; ③ Those with congenital nutritional malabsorption diseases, bone diseases, endocrine diseases, genetic metabolic diseases and those with serious complications; ④ Those whose short stature is caused by other diseases and who have been treated with growth hormone, AI, IGF-1 and other drugs; ⑤ Those with poor compliance, who have not followed the prescribed treatment or whose clinical data is incomplete and affect the determination of efficacy.

[0060] (3) Dropout criteria: ① Children with poor compliance or who voluntarily request to withdraw from the clinical trial; ② Children who experience serious adverse events (such as allergies to the drugs used) and should be withdrawn from the clinical trial according to the doctor's judgment; ③ Children who are included but do not take the medication as prescribed, have insufficient treatment duration, or whose case reports are incomplete.

[0061] (4) Exclusion criteria: ① Those who fail to complete clinical and laboratory observation items, affecting the judgment of efficacy and safety; ② Those who suffer from diseases that affect growth and development during the intervention and treatment process.

[0062] Treatment plan

[0063] Control group: Comprehensive intervention treatment was given. (1) Dietary guidance: reasonable feeding, balanced diet, cultivation of good eating habits, reduction of sweet snack intake, timely addition of nutrients, and attention to food hygiene. (2) Exercise prescription: continuous rope skipping or empty-handed jumping for half an hour every day, with a heart rate of 130 beats / minute being effective. Rope skipping recommendation: 500 skips / day for children 5 years old and under 7 years old; 500-1000 skips / day for children 7 years old, with each rest time not exceeding 1 minute.

[0064] Experimental group: Pediatric Tongdu Wenyang Ointment was used as a medium for traditional Chinese medicine. The ointment was applied to the treatment site, combined with massage techniques, and comprehensive intervention treatment was also given.

[0065] (1) Preparation of growth ointment: Panax notoginseng 3g, cinnamon 9g, hawthorn 10g, mulberry twig 10g, salvia miltiorrhiza 10g, corydalis yanhusuo 10g, epimedium 9g, drynaria fortunei 9g, and dipsacus asper 9g are one dose. After the above drugs are decocted and concentrated, triethanolamine, glycerin, petrolatum, etc. are added and prepared into 30g ointment medium according to a certain ratio for later use.

[0066] (2) Massage Techniques for Applying the Warming Yang Plaster to the Du Meridian: In the supine position, the massage focuses on tonifying the spleen and kidney meridians by massaging Qihai, Guanyuan, Zusanli, Yongquan, and abdominal massage; in the prone position, the massage focuses on massaging Pishu and Shenshu, rubbing the Du meridian and bladder meridian, and pinching the spine. The specific steps are as follows:

[0067] Supine position procedures: ① Tonifying the Spleen Meridian: The doctor uses their left thumb and index finger to stabilize the child's thumb, with the spiral side of the fingers facing upwards. The doctor places their right thumb, with the spiral side of the child's thumb as the point of contact, on the radial side of the child's thumb and gently pushes along the fingertip to the base, approximately 300 times, at a frequency of about 150-200 times per minute. ② Tonifying the Kidney Meridian: The child's little finger is placed with its spiral side facing upwards, inside the doctor's left hand. The right thumb gently pushes along the tip of the little finger to the base, approximately 300 times, at a frequency of about 150-200 times per minute. ③ Abdominal Massage: With the child supine, a circle is drawn with the line connecting the Shangwan and Guanyuan acupoints as its diameter. The doctor, with four fingers together, massages the abdomen clockwise around this circle 300-500 times. ④ Rubbing the Qihai and Guanyuan acupoints: With the child supine, the doctor places the pads of their index and middle fingers on the Guanyuan and Qihai acupoints respectively, applying pressure until the skin is depressed by 3-5 mm, and massages clockwise for 3 minutes. ⑤ Press and rub Zusanli (ST36): With the child lying on their back, the practitioner places the pad of their thumb on the Zusanli acupoint, applying pressure until the skin is depressed by 3-5 mm, and press and rub in a clockwise direction for 3 minutes. ⑥ Press and rub Yongquan (KI1): With the child lying on their back, the practitioner places the pad of their thumb on the Yongquan acupoint, applying pressure until the skin is depressed by 3-5 mm, and press and rub in a clockwise direction for 3 minutes.

[0068] Prone position manipulation: ① Kneading and pressing the spleen, stomach, and kidney points: With the child in a prone position, the practitioner places the pad of their thumb on the acupoints, applying pressure until the skin is depressed by 3-5 mm, and kneads and presses clockwise 30 times. ② Warming the Du meridian by rubbing: Apply growth cream to the Changqiang point (located at the base of the spine) and the bladder meridian areas on both sides of the back. The practitioner first rubs the Du meridian with the hypothenar eminence of their right hand, then rubs the bladder meridian on both sides of the lower back with their palm until a slight warmth is felt. ③ Pinching and Tapping the Governing Vessel: The child lies prone. The practitioner uses the sides of both thumbs to press against the skin of the child's back, with the index and middle fingers placed in front of the thumbs. Simultaneously, all three fingers forcefully lift and pinch the skin along the Governing Vessel and the Huatuo Jiaji points, from 2cm above the Changqiang point to the Dazhui point, repeating this pinching and lifting motion 3-6 times. Then, the practitioner's fingers are naturally bent and joined together, and along the Governing Vessel and the Huatuo Jiaji points on both sides, from the Dazhui point downwards to the Yaoshu point, tapping 3-5 times. The tapping force should be such that the skin is indented 2-3mm, at a frequency of 160-180 times per minute. This concludes the treatment.

[0069] Treatment time and course: Every spring from March to May, for two consecutive years. Treatment every two days, 10 times per course, for two courses.

[0070] Observation items and indicators

[0071] (1) Before treatment, a questionnaire and CRF form should be completed; the evaluation should be based on the standard deviation table of height and weight of children and adolescents aged 0-18 years to assess height, weight, and overall nutritional status, etc., and should be completed by a specialist based on the parents' statements (including birth history, parents' height, diet, exercise, sleep, diseases, psychological conditions, etc.) and examination results.

[0072] (2) Observe the growth values ​​of height and weight (record once every three months after treatment). Height and weight are measured by the same person, the same measuring instrument, and the same time period. Calculate the annual growth rate, height standard deviation (SDS), etc.

[0073] (3) Observe the improvement of appetite, food intake, picky eating and TCM syndrome scores.

[0074] (4) Laboratory indicators: serum IGF-1 and IGFBP-3 levels, which were rechecked once every six months before and after treatment.

[0075] (5) Bone age X-ray (bone age determination is performed using X-rays of the wrist and finger joints of the hand: the left wrist and finger joints are taken, or the right wrist and finger joints are taken if the patient is left-handed, energy 50mA, anteroposterior view. Based on AI bone age software, the GP atlas is selected and combined with the CHN method to make bone age judgment and predict final height); bone age is monitored before treatment and every 6 months thereafter.

[0076] (6) Follow-up period: Follow-up is conducted every 3 months after treatment and a re-examination is performed every 6 months for 2 years to observe for any adverse reactions.

[0077] Efficacy evaluation criteria

[0078] Criteria for Evaluating the Efficacy of Disease Treatment

[0079] (1) Significant effect: Height increased by ≥1 SD compared to before treatment, weight increased by >0.5 kg, appetite increased significantly, food intake increased, original symptoms basically disappeared, total TCM syndrome score improved by >70%, and all laboratory indicators returned to normal.

[0080] (2) Effective: Height increased by ≥0.5SD compared to before treatment, weight increased by >0.25kg, appetite improved, food intake increased, original symptoms improved, total TCM syndrome score improved by >30%, and various indicators or a certain indicator improved.

[0081] (3) Ineffective: Height increased by <0.5SD compared to before treatment, weight increased by <0.25kg, no improvement in symptoms such as food intake and appetite, improvement of total TCM syndrome score by <30%, and no improvement in any indicators.

[0082] Traditional Chinese Medicine Syndrome Scoring Standard: Quantitative scoring of primary and secondary symptoms.

[0083] (1) Main syndrome scores:

[0084]

[0085] (2) Integral of secondary symptoms:

[0086]

[0087] Safety assessment

[0088] Record any unexpected situations that occur during the implementation of the two methods on the observation form. For example, if the child experiences nausea, vomiting, or fainting during the ointment massage treatment, or if the child with sensitive skin experiences local skin redness, slight numbness or itching, or pain, or even allergic reactions or infections after the ointment massage, analyze the causes to evaluate the safety of the external treatment method of traditional Chinese medicine. Symptoms such as slightly dry mouth or sticky stools of varying degrees are all within the range of therapeutic effects.

[0089] Quality control and data management

[0090] Before the research project, relevant personnel were trained and their respective roles were clearly defined. After the research began, relevant personnel were subject to supervision and guidance from time to time throughout the research process. The design and research of the project strictly adhered to the principles of randomization and blinding, ensuring that the roles of researchers, operators, observers, and statistical analysts were clearly defined, each performing their own duties without interfering with each other.

[0091] Statistical analysis

[0092] SPSS 20.0 statistical software was used for data analysis. For variables with normal distribution, t-tests were used; for variables with non-normal distribution, nonparametric tests were used. Pearson correlation analysis or Spearman rank correlation analysis was used to analyze correlations between two groups. One-way ANOVA was used for comparisons among multiple groups; LSD test was used for homogeneous variances, and Tamhane's T2 test was used for unequal variances. Data are presented as mean ± standard deviation. P < 0.05 indicates a statistically significant difference.

[0093] Example 7

[0094] Preliminary clinical trial basis

[0095] Sixty children with short stature (male-to-female ratio 1:1) who received treatment in the spring of two consecutive years between March 2022 and May 2024 were selected and randomly divided into a treatment group and a control group, with 30 children in each group (mean age in the treatment group was 4.69 ± 1.41 years; mean age in the control group was 5.13 ± 1.16 years). There were no statistically significant differences in gender, age, disease duration, or other general characteristics between the two groups (P > 0.05), making them comparable. Inclusion criteria: ① Height within -2SD to -1SD for children of the same race, sex, and age, excluding children with congenital malabsorption disorders, skeletal diseases, endocrine disorders, chronic systemic diseases, and those with serious complications; ② Traditional Chinese medicine diagnosis conforming to the spleen and kidney deficiency type (symptoms include short stature or slow growth rate, anorexia or refusal to eat, picky eating, thin physique, sallow or pale complexion, fatigue, abdominal distension, loose stools or constipation, easy sweating, pale tongue with thin white coating, and deep, thready, and weak pulse); ③ Age range between 3 and 7 years old, regardless of sex, but without secondary sexual characteristics and not yet in puberty; ④ Not using growth hormone, anabolic steroids, or other drugs to treat this disease; ⑤ The guardian is informed about the child's condition and treatment and gives consent, is not in other clinical trials, has good compliance, and has signed an informed consent form.

[0096] Treatment results

[0097] The clinical efficacy of the two groups was compared. In the treatment group (n=30), 10 cases showed significant improvement, 18 cases showed improvement, and 2 cases showed no improvement, with a total effective rate of 93.3%. In the control group (n=30), 3 cases showed significant improvement, 11 cases showed improvement, and 16 cases showed no improvement, with a total effective rate of 46.7%. The difference between the two groups was statistically significant (P<0.01). See Table 1 for details.

[0098] Table 1. Comparison of clinical efficacy between the two groups (cases, percentages)

[0099]

[0100] Note: *P<0.01 compared with the control group.

[0101] Comparison of height standard deviation, bone age, and growth rate before and after treatment between the two groups: After treatment, the height standard deviation, bone age, and growth rate in the treatment group were all higher than those in the control group, and the differences were statistically significant (P < 0.01), while there was no difference in bone age before and after treatment (P > 0.05). See Table 2 for details.

[0102] Table 2 Comparison of standard deviation of height, bone age, and growth rate before and after treatment in the two groups.

[0103]

[0104] Note: Compared with the group before treatment, *P<0.05; compared with the control group, #P<0.01; &P>0.05

[0105] Before and after treatment, the IGF-1 level in the treatment group was significantly higher than that in the control group (P < 0.05). See Table 3 for details.

[0106] Table 3 Comparison of IGF-1 levels before and after treatment in the two groups of children

[0107]

[0108] Note: *P<0.05 compared with the group before treatment; #P<0.01 compared with the control group.

[0109] Example 8

[0110] Case 1

[0111] Zhang, male, 5 years and 2 months old, first visit on March 5, 2022, the solar term Jingzhe.

[0112] Chief complaint: Slow growth in height for 3 years.

[0113] Present Illness: The child's height growth over the past 3 years has been slower than that of children of the same age (annual growth ≤5cm). The child is a picky eater, prefers quiet activities and dislikes exercise, and experiences cold hands and feet in winter. Previous examinations at another hospital ruled out growth hormone deficiency and thyroid dysfunction. The parents refused growth hormone treatment and therefore sought intervention from traditional Chinese medicine.

[0114] Immediate diagnosis:

[0115] Height: 102cm (<-1.8SD, below the standard for the same age and gender)

[0116] Weight: 15kg(<-1.5SD)

[0117] Symptoms include a thin and weak physique, soft muscles, sallow complexion, poor appetite, irregular bowel movements, occasional bedwetting at night, averaging once a week, pale and swollen tongue with a white coating, and a deep and thready pulse.

[0118] Western medical examination (before treatment):

[0119] Bone age: 4 years (delayed by 1.2 years); Serum IGF-1: 98 ng / mL (↓, normal range 110-300 ng / mL); Trace elements: Zinc 58 μg / dL (↓, normal 60-110 μg / dL); 25-hydroxyvitamin D3: 18 ng / mL (↓, deficiency).

[0120] Western medical diagnosis: Idiopathic short stature

[0121] Traditional Chinese Medicine Diagnosis: Five Delays (Spleen and Kidney Deficiency Syndrome)

[0122] Pathogenesis: Deficiency of kidney essence, impaired spleen function, insufficient production of qi and blood, and malnourishment of bones.

[0123] Treatment principle: Warm the kidneys and strengthen the spleen, promote blood circulation and unblock the meridians.

[0124] Treatment plan: Pediatric Tongdu Wenyang Ointment Massage Therapy (Patented Formula)

[0125] Formula: Cinnamon 9g, Drynaria fortunei 9g, Epimedium 9g, Dipsacus asper 9g, Salvia miltiorrhiza 10g, Panax notoginseng 3g, Crataegus pinnatifida 10g, Morus alba twig 10g, Corydalis yanhusuo 10g

[0126] Preparation: Concentrate the decoction and add triethanolamine transdermal agent to make an ointment.

[0127] Massage therapy (3 times a week):

[0128] (1) Supine position: tonify the spleen meridian 300 times, tonify the kidney meridian 300 times, massage the abdomen for 5 minutes, and press Zusanli (ST36).

[0129] (2) Prone position: Rubbing the Du meridian and Bladder meridian, pinching the spine 6 times, pressing the Spleen Shu and Kidney Shu points.

[0130] Comprehensive intervention: 500 jump ropes daily (heart rate ≥130 beats / min), supplement with vitamin D 800 IU / day and zinc gluconate 5 mg / day.

[0131] Treatment course: Two consecutive spring cycles (March-May each year, for a total of 2 years).

[0132] Results after 2 years of treatment:

[0133]

[0134] Symptoms improved: appetite increased significantly, weight increased to 18kg (+3kg); stools became formed, bedwetting stopped; complexion became rosy, and physical strength improved significantly.

[0135] Efficacy assessment: Significant effect (height increase ≥1 SD, significant catch-up in IGF-1 and bone age)

[0136] Case 2

[0137] Ms. Wang, female, 6 years and 3 months old, first visit on March 20, 2022, the Spring Equinox.

[0138] Chief complaint: Delayed height growth for 2 years, accompanied by occasional knee pain.

[0139] Present Illness: The child's height has increased slowly over the past two years, by only 5 cm per year. He occasionally experiences knee pain and discomfort at night, often crying due to the pain. The frequency of these episodes has increased in the last half month. He is generally irritable, has a poor appetite, eats slowly (often exceeding 40 minutes), has regular bowel movements, and sometimes has bad breath in the morning. His tongue is pale with a white coating, and his pulse is deep and thready.

[0140] Auxiliary examinations:

[0141] Height: 112.8cm (<-1.3SD)

[0142] Bone age: 5.5 years, delayed by 0.8 years

[0143] Serum IGF-1: 138.2 ng / mL, borderline decreased (lower limit of normal 150 ng / mL)

[0144] 25(OH)D3: 22.4 ng / mL, insufficient (>30 ng / mL is sufficient)

[0145] Blood zinc: 62.1 μg / dL, borderline deficiency (lower limit 60 μg / dL)

[0146] Western medicine diagnosis: growth retardation

[0147] Traditional Chinese Medicine Diagnosis: Five Delays

[0148] Key points of TCM diagnosis: Deficiency of both spleen and kidney with blood stasis; growing pains indicate obstructed blood vessels.

[0149] Treatment principle: Tonify the kidneys and spleen, promote blood circulation and unblock the meridians.

[0150] Treatment plan: Pediatric Tongdu Wenyang Ointment Massage Therapy (Patented Formula Slightly Adjusted)

[0151] Formula: Cinnamon 6g, Drynaria fortunei 9g, Epimedium 6g, Dipsacus asper 10g, Salvia miltiorrhiza 12g, Panax notoginseng 3g, Crataegus pinnatifida 10g, Morus alba twig 12g, Corydalis yanhusuo 12g

[0152] The dosage of the original prescription drug was adjusted to enhance blood circulation and unblock the meridians, thereby relieving growing pains and achieving the goal of nourishing blood and unblocking the meridians without harming the body's vital energy.

[0153] Preparation: Concentrate the decoction and add triethanolamine transdermal agent to make an ointment.

[0154] Massage therapy (3 times a week):

[0155] (1) Supine position: tonify the spleen meridian 300 times, tonify the kidney meridian 200 times, massage the abdomen for 5 minutes, press Zusanli (ST36), apply ointment around the knee and use the thenar eminence kneading method for 5 minutes.

[0156] (2) Prone position: Rubbing the Du meridian and Bladder meridian, pinching the spine 6 times, and pressing the Spleen and Kidney points.

[0157] Comprehensive intervention: 500 jump ropes daily (heart rate ≥130 beats / min), supplement with vitamin D 800 IU / day and zinc gluconate 5 mg / day.

[0158] Treatment course: Two consecutive spring cycles (March-May each year, for a total of 2 years).

[0159] Treatment dynamic monitoring (changes in core data):

[0160] (I) Treatment lasted for 6 months (September 2022)

[0161] index Before treatment After treatment change Height (cm) 112.8 115.9 +3.1cm Bone age 5.5 years old 6.0 years old Catching up by 0.5 years IGF-1 (ng / mL) 138.2 183.6 32.8％↑ <![CDATA[25(OH)D3(ng / mL)]]> 22.4 36.8 64.3％↑ Frequency of growing pains 3 times / week 1 time / month 85％↓

[0162] (II) Treatment lasted 24 months (March 2024)

[0163]

[0164] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A traditional Chinese medicine composition for promoting growth and development in children with short stature due to spleen and kidney deficiency, characterized in that, include: Panax notoginseng, cinnamon, hawthorn, mulberry twigs, salvia miltiorrhiza, corydalis rhizome, epimedium, drynaria rhizome, and dipsacus root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The raw materials in the herbal composition are in the following proportions by weight: Panax notoginseng 1-5 parts, cinnamon 6-12 parts, hawthorn 7-13 parts, mulberry twig 7-13 parts, salvia miltiorrhiza 7-13 parts, corydalis yanhusuo 7-13 parts, epimedium 6-12 parts, drynaria fortunei 6-12 parts, and dipsacus asper 6-12 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that: The raw materials of the Chinese herbal composition are in the following weight ratios: Panax notoginseng 3 parts, cinnamon 9 parts, hawthorn 10 parts, mulberry twig 10 parts, salvia miltiorrhiza 10 parts, corydalis yanhusuo 10 parts, epimedium 9 parts, drynaria fortunei 9 parts, and dipsacus asper 9 parts.

4. A traditional Chinese medicine product that promotes growth and development in children with short stature due to spleen and kidney deficiency, characterized in that: The traditional Chinese medicine product is an external application prepared from the traditional Chinese medicine composition according to any one of claims 1-3.

5. The traditional Chinese medicine product as described in claim 4, characterized in that: The external application agents include, but are not limited to, decoctions, tinctures, ointments, and oils.

6. The traditional Chinese medicine product as described in claim 4, characterized in that: The external application preparation consists of 3g of Panax notoginseng, 9g of cinnamon, 10g of hawthorn, 10g of mulberry twig, 10g of Salvia miltiorrhiza, 10g of Corydalis yanhusuo, 9g of Epimedium, 9g of Drynaria fortunei, and 9g of Dipsacus asper. After the above herbs are decocted and concentrated, 20g of triethanolamine, 100g of glycerin, 120g of stearic acid, and 200g of petrolatum are added to each 560g serving of the decoction. Each 1ml of the decoction is equivalent to 1g of Chinese herbal medicine slices. One batch yields 1000g of finished product, and each box contains 30g of ointment medium for later use.

7. The application of the traditional Chinese medicine composition according to any one of claims 1-3 as a drug for promoting the growth and development of children with short stature due to spleen and kidney deficiency.

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