Traditional Chinese medicine composition for treating children's developmental retardation and bone age abnormality and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating child development retardation and bone age abnormity and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition comprises the following raw materials by weight: 8-20 parts of radix fici simplicissimae, 4-15 parts of bighead atractylodes rhizome, 4-12 parts of radix clematidis, 8-18 parts of Chinese angelica, 5-16 parts of teasel root, and 5-16 parts of white peony root; the invention further discloses a preparation method and application of the traditional Chinese medicine composition. According to the invention, through three-dimensional linkage of tonifying spleen and kidney to consolidate foundation and fire, nourishing qi and blood to charge sources and dredging meridians and collaterals to improve efficiency, the core targets of inhibiting abnormal bone age progression, promoting growth and strengthening muscles and bones are achieved. Wherein the radix clematidis has the characteristics of dredging meridians and removing bone sticking and can assist in regulating bone metabolism and dredging the drug efficacy path. The composition has the effect of clinically inhibiting the bone age abnormal progress caused by precocious puberty, and becomes a characteristic synergistic key for treating the dwarf disease and inhibiting the bone age abnormal progress. The whole formula gives consideration to inhibition of pathological bone age development and excitation of physiological growth potential, and a traditional Chinese medicine solution for treating both symptoms and root causes is provided for children with growth and development disorders.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition for treating developmental delay and abnormal bone age in children and its application. Background Technology

[0002] Developmental delay and abnormal bone age progression are two common developmental disorders in pediatric clinics, with complex pathological mechanisms and potential correlations. Modern medical research shows that developmental delay is characterized by lag in multiple areas of development, including physical, motor, language, and cognitive development, while abnormal bone age progression is mainly due to precocious puberty, premature development of secondary sexual characteristics, and abnormally advanced bone age. Currently, the treatment of developmental delay and abnormal bone age progression in children is mainly based on Western medicine, which has significant limitations. Western medicine mainly treats developmental delay with growth hormone replacement therapy, but long-term use may cause side effects such as abnormal glucose metabolism, hypothyroidism, and scoliosis. For abnormal bone age progression caused by precocious puberty, gonadotropin-releasing hormone analogs (GnRHa) are used to inhibit sexual development, but this may limit the potential for final height growth.

[0003] Traditional Chinese medicine (TCM) theory holds that developmental delay is related to spleen and kidney deficiency and insufficient qi and blood. Precocious puberty, which leads to abnormal bone age progression, is often caused by yin deficiency with excessive fire and liver stagnation transforming into fire. While traditional Chinese medicine oral formulas (such as Liuwei Dihuang Wan and Dabu Yin Wan) can regulate yin and yang balance, children's spleen and stomach functions are relatively weak, and long-term use can easily lead to adverse reactions such as abdominal distension and diarrhea. Furthermore, children's resistance to bitter Chinese medicine results in low compliance. Current research on external application of Chinese medicine mainly focuses on acupoint application, but a systemic external application regimen targeting the comorbidities of developmental delay and abnormal bone age progression has not yet been reported. Although some clinical studies have shown that external Chinese medicine has the advantages of definite efficacy and few side effects in the treatment of precocious puberty, research on its pharmacological mechanisms, formulation rules, and correlation with developmental delay remains insufficient.

[0004] While some studies have mentioned the adjunctive therapeutic effects of topical administration on childhood coughs and anorexia, there is still a lack of specialized herbal foot bath compositions targeting developmental delay and abnormal bone age progression. Existing technologies have failed to effectively address the combined intervention challenges of comorbid developmental delay and abnormal bone age progression in children, and the anticipated short stature in adulthood. Furthermore, long-term use of herbal compositions by children can easily lead to adverse reactions such as abdominal distension and diarrhea, and patient resistance to the bitter taste of herbal medicines results in low compliance. Therefore, this invention aims to achieve the dual goals of simultaneously regulating abnormal bone age progression and promoting growth and development through the scientific formulation of topical herbal medicines. Summary of the Invention

[0005] To address the issues of adverse reactions such as abdominal distension and diarrhea caused by long-term use of traditional Chinese medicine compositions in children with precocious puberty and developmental delays and abnormal bone age, and the low compliance due to patient resistance to bitter-tasting traditional Chinese medicines, this application provides a traditional Chinese medicine composition for treating developmental delays and abnormal bone age in children and its application, as detailed below:

[0006] A traditional Chinese medicine composition for treating developmental delay and abnormal bone age in children, comprising, by weight, the following raw materials: 8-20 parts of *Ficus hirta*, 4-15 parts of *Atractylodes macrocephala*, 4-12 parts of *Clematis chinensis*, 8-18 parts of *Angelica sinensis*, 5-16 parts of *Dipsacus asper*, and 5-16 parts of *Paeonia lactiflora*.

[0007] Preferably, the ingredients, by weight, include the following: 11-18 parts of *Ficus hirta* and 6-12 parts of *Atractylodes macrocephala*.

[0008] The ingredients are: Clematis chinensis 4-9 parts, Angelica sinensis 10-15 parts, Dipsacus asper 8-13 parts, and Paeonia lactiflora 8-13 parts.

[0009] Preferably, the ingredients, by weight, include the following: 14-16 parts of *Ficus hirta* and 7-9 parts of *Atractylodes macrocephala*.

[0010] The ingredients are: Clematis chinensis 4-6 parts, Angelica sinensis 11-13 parts, Dipsacus asper 9-11 parts, and Paeonia lactiflora 9-11 parts.

[0011] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating developmental delay and abnormal bone age in children.

[0012] The present invention also provides a medicament for treating developmental delay and abnormal bone age in children, comprising the traditional Chinese medicine composition for treating developmental delay and abnormal bone age in children as described above and pharmaceutically acceptable excipients.

[0013] Preferably, the dosage form of the drug is a traditional Chinese medicine external foot bath powder or a medicine pack.

[0014] Preferably, the preparation method of the drug is as follows:

[0015] Step 1: Weigh the raw materials according to the weight ratio, and after treatment to remove pesticide residues, desulfurize, and remove heavy metals, mechanically crush them into coarse powder and mix them evenly;

[0016] Step 2: Screen and filter the crude raw drug powder;

[0017] Step 3: Weigh and package the portions as needed.

[0018] Preferably, in step two, the raw material powder is passed through a 100-mesh sieve to remove dust.

[0019] Five-finger peach and angelica root serve as the principal herbs, establishing the overall formula's foundation. Five-finger peach, with the properties of "Southern Astragalus," strengthens the spleen and lungs without causing dryness, promotes qi circulation and eliminates dampness to harmonize the middle jiao, and relaxes muscles and tendons to unblock meridians. Targeting the fundamental goal of "strengthening the spleen," it promotes the transformation and transportation of nutrients from food, providing the material basis for growth and development. Angelica root nourishes and invigorates blood, replenishing the material basis for the generation of essence and blood, and through its properties of regulating menstruation and relieving pain, it ensures that the nourishment is not stagnant. Together with five-finger peach, it ensures a source for the generation of qi and blood, jointly constructing a transformation channel for nourishing the innate from the acquired.

[0020] Dipsacus asper and Atractylodes macrocephala serve as adjuvant herbs to enhance the core therapeutic effects. Dipsacus asper directly enters the liver and kidney meridians, tonifying the liver and kidneys and strengthening tendons and bones. Targeting the core objective of "tonifying the kidneys and promoting growth," it directly promotes bone development and strengthens tendons and bones through the physiological characteristics of the kidneys governing bone and marrow production and the liver governing tendons. Atractylodes macrocephala, as a key herb for strengthening the spleen, forms a double insurance for spleen-strengthening with Ficus hirta. By drying dampness and promoting diuresis, it enhances the function of the middle jiao (middle burner), consolidates the exterior and stops sweating to protect the vital energy, and achieves continuous nourishment of the acquired constitution. Together, they strengthen the spleen and remove dampness to subdue kidney fire, effectively slowing down the abnormal bone age progression of precocious puberty.

[0021] White peony root and Clematis chinensis serve as adjuvant herbs to enhance efficacy. White peony root soothes the liver and nourishes yin, working synergistically with Angelica sinensis to strengthen the liver and blood-nourishing effects. The liver governs the tendons, so nourishing the liver nourishes the tendons and promotes growth. Furthermore, the combination of these two herbs nourishes liver yin, replenishes liver blood, and suppresses liver fire, thus delaying the abnormal progression of bone age from its source. Clematis chinensis is primarily used to dispel wind and dampness and unblock the meridians. It not only clears away the pathogenic factors that obstruct the meridians but also guides other herbs directly to the tendons and bones through its pungent and dispersing properties. Clematis chinensis has multiple effects, including anti-inflammatory and analgesic properties, cartilage protection, liver protection, anti-cancer, antibacterial and antimicrobial properties, and hypoglycemic effects. Its meridian-unblocking properties can help regulate bone metabolism. In this formula, it works in combination with other herbs to exert a dual effect: on the one hand, softening abnormal bone spurs and improving joint function; on the other hand, inhibiting the rapid increase in bone age caused by precocious puberty, demonstrating its unique mechanism of unblocking the meridians and inhibiting bone age.

[0022] In addition, Clematis chinensis also serves as an adjuvant herb. Its pungent and dispersing properties permeate the entire formula. It acts as both an adjuvant herb to dispel pathogens and clear the meridians, and as an adjuvant herb to guide the medicinal power to be distributed throughout the limbs and bones, ensuring that the tonifying medicinal power is precisely applied to the muscles, bones and meridians, and avoiding the harm of congestion.

[0023] Compared with the prior art, the beneficial effects of the technical solution of the present invention are as follows:

[0024] This invention's traditional Chinese medicine composition focuses on tonifying the kidneys and spleen to promote growth. Targeting conditions such as short stature, growth retardation, and precocious puberty in children, it employs a well-ordered combination of principal, assistant, and adjuvant herbs to form a comprehensive treatment system that addresses both the spleen and kidneys, regulates qi and blood, combines tonification and purgation, and emphasizes both skeletal and musculoskeletal health. Through a three-dimensional synergy of tonifying the spleen and kidneys to strengthen the foundation and suppress pathogenic factors, nourishing qi and blood to replenish the source, and unblocking meridians to enhance efficacy, it achieves the core objectives of inhibiting abnormal bone age progression, promoting growth, and strengthening skeletal and musculoskeletal health. The meridian-clearing properties of Clematis chinensis help to unblock the pathways of medicinal effects and assist in regulating bone metabolism. In addition to unblocking the pathways of medicinal effects, it has been clinically observed to inhibit abnormal bone age progression caused by precocious puberty. Combined with the entire formula, it has a unique synergistic effect in treating short stature and regulating bone age. The entire formula addresses both the inhibition of pathological bone age progression and the stimulation of physiological growth potential, providing a comprehensive TCM solution for children's growth and development disorders. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0026] The formulation of this application achieves the core goals of promoting growth and strengthening bones and muscles through a three-dimensional approach: tonifying the spleen and kidneys to strengthen the foundation, nourishing qi and blood to replenish the source, and unblocking meridians to enhance efficacy. The formula comprehensively addresses both inhibiting pathological bone age progression and stimulating physiological growth potential, providing a holistic TCM solution for children's growth and development disorders. The specific implementation method is as follows:

[0027] This invention provides a traditional Chinese medicine composition for treating developmental delay and abnormal bone age in children, comprising the following raw materials by weight: 8-20 parts of Ficus hirta, 4-15 parts of Atractylodes macrocephala, 4-12 parts of Clematis chinensis, 8-18 parts of Angelica sinensis, 5-16 parts of Dipsacus asper, and 5-16 parts of Paeonia lactiflora.

[0028] As a preferred embodiment, the ingredients, by weight, include the following: 11-18 parts of Ficus hirta, 6-12 parts of Atractylodes macrocephala, 4-9 parts of Clematis chinensis, 10-15 parts of Angelica sinensis, 8-13 parts of Dipsacus asper, and 8-13 parts of Paeonia lactiflora.

[0029] As a preferred embodiment, the ingredients, by weight, include the following: 14-16 parts of Ficus hirta, 7-9 parts of Atractylodes macrocephala, 4-6 parts of Clematis chinensis, 11-13 parts of Angelica sinensis, 9-11 parts of Dipsacus asper, and 9-11 parts of Paeonia lactiflora.

[0030] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating developmental delay and abnormal bone age in children.

[0031] This embodiment also provides a drug for treating developmental delay and abnormal bone age in children, comprising the traditional Chinese medicine composition for treating developmental delay and abnormal bone age in children as described above and pharmaceutically acceptable excipients.

[0032] In a preferred embodiment, the dosage form of the drug is a traditional Chinese medicine external powder, preferably a foot bath powder or a medicine pack.

[0033] Here, the drug is preferably a topical preparation (such as a foot bath powder) that exerts its therapeutic effect through transdermal absorption, avoiding gastrointestinal discomfort and compliance problems caused by oral administration.

[0034] As a preferred embodiment, the preparation method of the drug is as follows:

[0035] Step 1: Weigh the raw materials according to the weight ratio, and after treatment to remove pesticide residues, desulfurize, and remove heavy metals, mechanically crush them into coarse powder and mix them evenly;

[0036] Step 2: Screen and filter the crude raw drug powder;

[0037] Step 3: Weigh and package the portions as needed.

[0038] In a preferred embodiment, in step two, the raw material powder is passed through a 100-mesh sieve to remove dust.

[0039] In this invention, the formula combines the spleen and kidneys with the effects of *Ficus hirta* (a type of herb), *Angelica sinensis* (a herb) to strengthen the spleen and kidneys and fortify tendons and bones, and *Dipsacus asper* (a herb) and *Atractylodes macrocephala* (a herb) to strengthen the spleen, suppress internal heat, and replenish qi and blood, forming the core strength. *Angelica sinensis* and *Paeonia lactiflora* (a herb) nourish blood, invigorate blood circulation, nourish the liver, astringe yin, and suppress liver fire, providing nourishment to tendons and bones and preventing stagnation of tonifying herbs. This balances qi and blood while inhibiting abnormal bone age progression. *Clematis chinensis* (an herb) unblocks meridians, relieves pain, and dispels wind and dampness (as an adjuvant), clearing the meridians and eliminating pathogenic factors, allowing the tonifying herbs to reach the tendons and bones effectively. This is the finishing touch in the formula, avoiding the potential for stagnation that might result from simple tonification. *Clematis chinensis*'s ability to unblock meridians promotes the flow of qi, blood, and essence to the tendons and bones, which is a key feature and enhances the efficacy of this formula.

[0040] In addition, the external application route allows for drug absorption through the meridians of the foot, providing localized drug delivery and systemic regulation. The foot is the intersection of the three Yin and three Yang meridians of the foot, allowing drug components to penetrate the skin to acupoints and regulate spleen and kidney function and the endocrine axis. It has high safety by avoiding the first-pass effect of the liver and reducing drug toxicity, making it especially suitable for children whose liver and kidney functions are not fully developed. It also has good compliance, is easy to operate, and is highly accepted by children, allowing for long-term adherence.

[0041] The present invention will be further described in detail below with reference to specific embodiments:

[0042] Example 1

[0043] Preparation of the powder form of the traditional Chinese medicine composition of the present invention (I)

[0044] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 15 parts of *Ficus hirta*, 8 parts of *Atractylodes macrocephala*, 5 parts of *Clematis chinensis*, 12 parts of *Angelica sinensis*, 10 parts of *Dipsacus asper*, and 10 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0045] Step 1: Mechanically crush into coarse powder and mix evenly;

[0046] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0047] Step 3: Weigh and package the portions.

[0048] Example 2

[0049] Preparation of the powder form of the traditional Chinese medicine composition of the present invention (II)

[0050] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 16 parts of *Ficus hirta*, 8 parts of *Atractylodes macrocephala*, 6 parts of *Clematis chinensis*, 11 parts of *Angelica sinensis*, 10 parts of *Dipsacus asper*, and 9 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0051] Step 1: Mechanically crush into coarse powder and mix evenly;

[0052] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0053] Step 3: Weigh and package the portions as needed.

[0054] Example 3

[0055] Preparation of the powder form of the traditional Chinese medicine composition of the present invention (III)

[0056] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 15 parts of *Ficus hirta*, 7 parts of *Atractylodes macrocephala*, 5 parts of *Clematis chinensis*, 15 parts of *Angelica sinensis*, 13 parts of *Dipsacus asper*, and 9 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0057] Step 1: Mechanically crush into coarse powder and mix evenly;

[0058] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0059] Step 3: Weigh and package the portions.

[0060] Example 4

[0061] Preparation of the powder form of the traditional Chinese medicine composition of the present invention (IV)

[0062] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 14 parts of *Ficus hirta*, 8 parts of *Atractylodes macrocephala*, 6 parts of *Clematis chinensis*, 11 parts of *Angelica sinensis*, 9 parts of *Dipsacus asper*, and 9 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0063] Step 1: Mechanically crush into coarse powder and mix evenly;

[0064] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0065] Step 3: Weigh and package the portions.

[0066] Example 5

[0067] Preparation of the powder form of the traditional Chinese medicine composition of the present invention (V)

[0068] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 16 parts of *Ficus hirta*, 10 parts of *Atractylodes macrocephala*, 4 parts of *Clematis chinensis*, 14 parts of *Angelica sinensis*, 12 parts of *Dipsacus asper*, and 11 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0069] Step 1: Mechanically crush into coarse powder and mix evenly;

[0070] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0071] Step 3: Weigh and package the portions.

[0072] Example 6

[0073] Preparation of the powder form of the traditional Chinese medicine composition of the present invention (VI)

[0074] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 16 parts of *Ficus hirta*, 7 parts of *Atractylodes macrocephala*, 5 parts of *Clematis chinensis*, 12 parts of *Angelica sinensis*, 11 parts of *Dipsacus asper*, and 10 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0075] Step 1: Mechanically crush into coarse powder and mix evenly;

[0076] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0077] Step 3: Weigh and package the portions as needed.

[0078] Example 7

[0079] Preparation of the medicine package for the traditional Chinese medicine composition of the present invention (I)

[0080] Weigh the following medicinal materials, which have undergone pesticide residue removal, desulfurization, and heavy metal removal treatment, according to their weight: 15 parts of *Ficus hirta*, 8 parts of *Atractylodes macrocephala*, 5 parts of *Clematis chinensis*, 12 parts of *Angelica sinensis*, 10 parts of *Dipsacus asper*, and 10 parts of *Paeonia lactiflora*. The preparation method is as follows:

[0081] Step 1: Mechanically crush into coarse powder and mix evenly;

[0082] Step 2: Pass the raw material coarse powder through a 100-mesh sieve to remove dust;

[0083] Step 3: Weigh out the required amount and pack it into a breathable non-woven fabric medicine bag.

[0084] Clinical trials of the traditional Chinese medicine composition of this invention

[0085] 1. Materials and Methods

[0086] 1.1 Research Subjects and Grouping

[0087] Sixty-seven patients aged 5-13 years who visited the pediatric outpatient department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine between January 2023 and June 2025, were randomly selected. These patients were diagnosed with short stature or abnormal bone age progression and had used at least the powder prepared in Example 1. Clinical symptoms and signs before and after application of the topical Chinese medicine composition were recorded through outpatient visits, electronic medical record systems, and telephone follow-ups. The efficacy in improving children's height was evaluated by comparing the improvement in clinical symptoms and signs.

[0088] 1.2 Diagnostic criteria

[0089] 1.2.1 Western Medicine Diagnostic Criteria

[0090] The diagnostic criteria were formulated with reference to the "Guidelines for the Diagnosis and Treatment of Precocious Puberty in Children Using Integrated Traditional Chinese and Western Medicine (2023 Edition)":

[0091] (a) Central precocious puberty

[0092] 1. Premature appearance of secondary sexual characteristics (meeting the defined age) and progressing according to the normal developmental schedule: Girls: breast development, a rapid increase in height, pubic hair development, and menarche generally occurs 2 years after breast development begins. Boys: testicular and penile enlargement, a rapid increase in height, pubic hair development, and voice change and nocturnal emission generally occur 2 years after testicular enlargement begins.

[0093] 2. There is evidence of gonadal development. For girls, it is determined by ultrasound imaging, and for boys, the testicular volume is ≥4ml.

[0094] 3. During development, there is a sudden increase in height.

[0095] 4. Gonadotropins rise to puberty levels.

[0096] 5. Advanced bone age may be present, but it is not a specific diagnostic criterion.

[0097] The most common type of incomplete central precocious puberty is simple premature breast development, which is characterized by premature breast development without the appearance of other secondary sexual characteristics. The areola is uncolored, and the disease has a non-progressive and self-limiting course. The breast usually disappears spontaneously after a few months.

[0098] (ii) Peripheral precocious puberty.

[0099] 1. Premature appearance of secondary sexual characteristics (meeting the defined age).

[0100] 2. Sexual characteristics do not develop according to the normal developmental process.

[0101] 3. Gonadal size is at the pre-pubertal level.

[0102] 4. Gonadotropin levels in pre-puberty.

[0103] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0104] Based on the "Guidelines for the Diagnosis and Treatment of Precocious Puberty in Children Using Integrated Traditional Chinese and Western Medicine (2023 Edition)" issued by the Pediatric Professional Committee of the China Association of Integrative Medicine, the following TCM diagnostic criteria are established:

[0105] (1) Clinical manifestations: Children develop secondary sexual characteristics before a certain age (before 7.5 years old for girls and before 9 years old for boys). Girls may have breast enlargement, areola development, pubic and axillary hair growth, increased vaginal discharge or menarche; boys may have testicular enlargement (volume ≥4ml), penis thickening, pubic and axillary hair growth, voice change or nocturnal emission; may be accompanied by accelerated growth and advanced bone age (>1 year).

[0106] (2) Syndrome types: ① Yin deficiency with fire excess syndrome; ② Liver stagnation transforming into fire syndrome; ③ Phlegm-dampness retention syndrome; ④ Other syndrome types that cannot be classified into the above three categories.

[0107] 1.3 Inclusion and Exclusion Criteria

[0108] 1.3.1 Inclusion criteria for developmental delay in children

[0109] (1) The primary diagnosis meets the diagnostic criteria for developmental delay in children in traditional Chinese medicine and the diagnostic criteria for developmental delay in children in Western medicine.

[0110] (2) Age between 4 and 14 years old, gender not limited; strong compliance, able to cooperate with external foot bath to complete the treatment course; informed consent from the guardian.

[0111] 1.3.2 Inclusion criteria for abnormal bone age progression

[0112] (1) Bone age is more than 1 year ahead of actual age.

[0113] (2) Boys develop secondary sexual characteristics and their testicular volume increases (>4ml).

[0114] (3) Girls develop secondary sexual characteristics, and their breasts begin to develop.

[0115] 1.3.2 Exclusion Criteria

[0116] (1)Combined with severe diseases of cardiovascular and cerebrovascular, mental diseases and other systems.

[0117] (2)Having a history of acute respiratory infection within the past two weeks or being in the acute stage of acute respiratory disease.

[0118] (3)Children with severe allergic constitution, allergic to traditional Chinese medicine ingredients, and children with damaged foot skin.

[0119] 1.4 Treatment plan and results

[0120] 1.4.1 Treatment plan

[0121] The treatment group was treated with the traditional Chinese medicine composition of Example 1 of the present invention. The medicinal materials in the formula were prepared into a powder according to 15 parts of Ficus hirta, 8 parts of Atractylodes macrocephala, 5 parts of Clematis chinensis, 12 parts of Angelica sinensis, 10 parts of Dipsacus asperoides, and 10 parts of Paeonia lactiflora. The control group was given oral traditional Chinese medicine (in a small number of cases, growth hormone injection was combined in the middle) for treatment.

[0122] Usage method: Each time, take 15 g and place it in a container, add 2000 ml of water, heat and decoct for 10 minutes, pour it into a foot bath container, then add about 2000 ml of water, cool it to about 40 °C, and soak the feet for 10 - 15 minutes. Once a day, and then it can be increased to twice a day, with at least 6 months of complete foot bath.

[0123] 1.4.2 Judgment criteria

[0124] Evaluate whether the standard is met according to the height change, symptoms and signs, and relevant laboratory test results before and after treatment.

[0125] (1)For the short stature group to meet the treatment standard, it is necessary to meet: ① The height velocity (HV) is significantly increased compared with that before treatment (≥ 3 cm / year); ② HV is close to or exceeds the P50 value of the growth rate of normal children matched with the same bone age (BA) (or ≥ 80% of the expected value); ③ The bone age advancement velocity (BAV) ≤ the actual age advancement velocity (CAV).

[0126] (2)For the group with abnormally advanced bone age to meet the treatment standard, it is necessary to meet: ① The bone age advancement is significantly slowed down (the BA / CA ratio decreases or BAV < CAV); ② HV is maintained within the normal range matched with its bone age (not lower than P10 - P25 matched with BA).

[0127] Record the basic vital signs, blood and urine routine, adverse reactions, etc. of the patients before and after the intervention. After drug-related adverse reactions occur, execute according to the termination standard.

[0128] 1.4.3 Treatment results

[0129] Calculate the improvement rate according to the symptom and sign scores before and after treatment, and evaluate the degree of improvement.

[0130] The treatment group included 15 adolescents who were shorter than average or met the criteria for short stature, comprising 8 boys and 7 girls. The oldest was 13 years old, and the youngest was 5 years old. The largest deviation from the age / height standard was 16 cm, and the smallest was 2 cm. The control group included 16 adolescents who were shorter than average or met the criteria for short stature, comprising 10 boys and 6 girls. The largest deviation from the age / height standard was 20 cm, and the smallest was 8 cm.

[0131] Children with precocious puberty or premature puberty and abnormal bone age were included in the treatment group and the control group, with 19 and 17 cases respectively. All of them were girls, the oldest being 12 years old and the youngest being 6 years old.

[0132] Results: The efficacy of the 67 subjects was evaluated after they had taken the powder prepared in Example 1 for 6 months. The results are shown in the table below.

[0133] Table 1. Comparison of treatment results between the two groups in the short stature or dwarfism group.

[0134] Table 2. Comparison of efficacy results between the two groups in the precocious puberty or early puberty group.

[0135] Table 3. Comparison of gonadotropin results before and after treatment in the treatment group and the control group.

[0136] This study compared the efficacy of combined traditional Chinese medicine powder foot bath with other conventional Chinese and Western medicine treatments in children with short stature / dwarfism (n=31) and children with precocious puberty / early puberty and abnormal bone age (n=36).

[0137] The results showed that in the short stature / dwarfism group, there was no statistically significant difference in the mean height increase (6.35±2.44cm vs 6.28±1.59cm) and target achievement rate (66.7% vs 56.3%) between the treatment group and the control group after 6 months of treatment (P>0.05). However, the clinical target achievement rate in the treatment group (66.7%) was significantly higher than that in the control group (56.3%). In the control group with precocious puberty / early puberty and abnormal bone age, the treatment group showed a significant advantage: after 6 months of treatment, the annual height growth rate in the treatment group (8.07±1.81cm / year) was significantly higher than that in the control group (7.29±2.16cm / year) (P=0.007), and the clinical target achievement rate (78.9%) was higher than that in the control group (70.6%).

[0138] Furthermore, the bone age / age ratio (BA / CA) in the treatment group after treatment (1.11±0.11) was closer to normal than that in the control group (1.01±0.06) (P=0.061, nearly significant), indicating that this formula helps delay the progression of bone age. There were no statistically significant differences in hormone levels (LH, FSH, LH / FSH) before and after treatment between the two groups (P>0.05).

[0139] The powder, based on the compound formula, is decocted in hot water and then used for foot baths. It invigorates the spleen (qi) to aid digestion and strengthens the kidneys (essence) to fortify bones, thereby promoting growth and development. It helps children improve other bodily dysfunctions caused by poor lifestyle habits and fundamentally treats developmental delay and precocious puberty.

[0140] 1.5 Specific Clinical Cases

[0141] Clinical Case 1: Pan XX, female, 12 years old, visited the clinic on August 12, 2024. At that time, her height was 142cm, which was only 2cm longer than the previous year, and her weight was 27.25kg. Because of her short stature, she always sat in the front row of the class. She had restless sleep, poor appetite, and was thin. She was instructed to use the powder foot bath obtained in Example 1 once a day for about 6 months. The child's height increased significantly compared to before. When she returned for a follow-up visit on March 27, 2025, her height was measured at 147cm and her weight at 30.5kg.

[0142] Clinical Case 2: Li XX, female, 10 years old, consulted on September 12, 2024. Her breasts had already begun to develop 3 years prior, and her height was also faster than her peers, reaching 146.1cm (0.52 SD). She was usually lively, with a good appetite and sleep. Gynecological ultrasound showed an endometrial thickness of 2.6mm, and she was diagnosed with central precocious puberty. She was instructed to use the powder obtained in Example 1 for external foot baths, once daily for 6 months. After 6 months (March 13, 2025), her height increased by 5cm. She continued oral Chinese medicine treatment. At her follow-up visit in May 2025, her height had reached 153cm, but sexual development was progressing slowly. A follow-up gynecological ultrasound on June 12, 2025, showed an endometrial thickness of 4.2mm, and her bone age was within the normal range.

[0143] Clinical Case 3: Huang XX, female, 11 years old, presented on September 9, 2023, with bilateral breast development for over a month. She was 130cm tall, with normal appetite and sleep, and good academic performance. Her secondary sexual characteristics (breast development, endometrial thickening) were precocious. Sex hormone tests showed elevated LH, FSH, and E2 levels, and IGF: 196 ng / ml. A sex hormone stimulation test showed LH / FSH > 0.57 (8.17 / 14.07). Western medicine diagnosed her with precocious puberty. Traditional Chinese medicine diagnosed her with Yin deficiency and excessive fire. She was instructed to use the powder prepared in Example 1 for external foot baths. After 6 months of treatment (March 28, 2024), her height increased by 6cm; after 11 months (August 21, 2024), her height increased by 10cm; and after 14 months (November 20, 2024), her height increased by 12cm. Without the use of Western medicine inhibitors, the child's height increased by 12 cm in 14 months. According to the bone age chart method, the child's bone age progressed to less than 1 year. In terms of sexual development, the endometrium grew from 0.12 mm to 0.2 mm in one year, an increase of only 0.08 mm.

[0144] Clinical Case 4: Liu XX, female, 9 years old, presented on August 30, 2023, with bilateral breast development for 1 year. At initial examination, her height was 137cm, and her breasts continued to develop, exceeding the 65th percentile for her age. Auxiliary examinations showed a slightly elevated E2 level (97.93 pmol / L), indicating a borderline state of sexual development, but with persistent LH suppression (<0.10 IU / L). Follicles were enlarged, with ≥5 antral follicles bilaterally (5 on the right and 6 on the left), the largest diameter being 6mm. Her bone age was slightly advanced by 9+ years. She was instructed to use the powder prepared in Example 1 for external foot bath once daily. At her follow-up visit in September 2024, her height had increased by 8.5cm, and her sexual development was progressing slowly, with her bone age within the normal range.

[0145] Clinical Case 5: Pu XX, male, 5 years old, had been growing slower than his peers for 3 years, with a height increase of less than 4cm in the past year (less than the average of 7cm / year for his age). He was seen on June 14, 2023, with a height of 105.7cm (-2.47SD). He was instructed to use the powder obtained in Example 1 for external foot bath once a day, along with a healthy diet, sleep and exercise. By July 2025, his height was 118.8cm (-1.94SD), an increase of 0.5SD, with an annual rate of 6.3cm / year, which is higher than his previous rate of 5cm / year.

[0146] Clinical Case 6: Gao XX, female, 10 years old. At the time of consultation, both breasts were developed and her height was below average. She was consulted on March 20, 2024, with a height of 125.2cm (-0.74SD). She was instructed to use the powder obtained in Example 1 for external foot bath once a day. On May 11, 2024, her height increased to 129cm. Her height increased by nearly 4cm in more than two months. In terms of secondary sexual characteristics, her breasts were still in stage B2 and the breast buds did not continue to enlarge.

[0147] The present invention has been further described above with reference to specific embodiments. However, it should be understood that the specific description herein should not be construed as limiting the nature and scope of the present invention. Various modifications made to the above embodiments by those skilled in the art after reading this specification are all within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating developmental retardation and bone age abnormality in children, characterized in that, By weight parts, including the following raw materials: Radix Fici Hirtae 8~20 parts, Atractylodes 4~15 parts, Radix Tronchophili 4~12 parts, Angelica 8~18 parts, Dipsacus 5~16 parts, Radix Paeoniae Alba 5~16 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight parts, including the following raw materials: Radix Fici Hirtae 11~18 parts, Atractylodes 6~12 parts, Radix Tronchophili 4~9 parts, Angelica 10~15 parts, Dipsacus 8~13 parts, Radix Paeoniae Alba 8~13 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight parts, including the following raw materials: Radix Fici Hirtae 14~16 parts, Atractylodes 7~9 parts, Radix Tronchophili 4~6 parts, Angelica 11~13 parts, Dipsacus 9~11 parts, Radix Paeoniae Alba 9~11 parts.

4. The use of the traditional Chinese medicine composition for treating developmental retardation and bone age abnormality of children according to any one of claims 1-3 in the preparation of a medicine for treating developmental retardation and bone age abnormality of children.

5. A medicament for treating developmental retardation and abnormal bone age in children, characterized by, The traditional Chinese medicine composition for treating developmental retardation and bone age abnormality of children according to any one of claims 1-3 and a pharmaceutically acceptable adjuvant.

6. The medicament for treating the retardation of development and abnormal bone age of children according to claim 5, wherein The dosage form of the medicine is a traditional Chinese medicine foot bath powder or a medicine bag for external use.

7. The method of claim 5 or 6, wherein the medicament for treating delayed development and abnormal bone age in children is prepared by, The preparation method of the medicine is as follows: Step one, the raw medicine is weighed according to the proportion by weight, and is treated by removing residual pesticides, removing sulfur and heavy metals, and mechanically crushing into coarse powder, and is mixed uniformly; Step two, the raw medicine coarse powder is screened and filtered; Step three, the medicine is packaged by weight, and is obtained.

8. The method of claim 7, wherein, In step two, the raw medicine coarse powder is screened through a 100 mesh sieve to remove dust.

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