External traditional Chinese medicine composition for promoting hair growth, relieving itching and controlling oil and application thereof

Abstract

The invention discloses an external traditional Chinese medicine composition for promoting hair growth, relieving itching and controlling oil and application of the external traditional Chinese medicine composition. Belongs to the technical field of alopecia prevention. The traditional Chinese medicine composition is prepared from radix salviae miltiorrhizae, radix angelicae sinensis, flos rosae rugosae, herba menthae, cortex mori, cortex dictamni, herba ecliptae, radix polygoni multiflori, sasangua cake, rhizoma zingiberis recens, fructus gleditsiae, fructus phyllanthi and folium mori. The traditional Chinese medicine composition lotion which is convenient to use is prepared by combining a traditional Chinese medicine composition extracting solution with a shampoo matrix. When the lotion is independently used, hair growth of a patient suffering from androgenetic alopecia can be promoted, and the hair density and the final hair density can be improved. When the lotion is used together with a conventional treatment scheme, the final hair density can be remarkably improved, the alopecia score of a patient is reduced, and scalp greasiness and itching are reduced. The traditional Chinese medicine composition lotion has no adverse reaction when being used independently or combined with a conventional treatment scheme, and is good in safety.

Description

Technical Field

[0001] This invention relates to the field of hair loss prevention and treatment technology, and more specifically to a topical traditional Chinese medicine composition for promoting hair growth, relieving itching and controlling oil production, and its application. Background Technology

[0002] Androgenetic alopecia (AGA) is the most common non-scarring hair loss, characterized by progressive miniaturization of hair follicles. In my country, the prevalence of AGA is 21% in men and 6% in women, with the incidence gradually increasing with age and the age of onset becoming increasingly younger. Patients experience impacted social activities, reduced quality of life, and are prone to anxiety and depression.

[0003] The clinical challenges of androgenetic alopecia lie in its long treatment course, poor patient comfort, relapse after discontinuation of medication, and low patient adherence to long-term medication. Androgenetic alopecia often involves a comprehensive approach combining topical medications, oral medications, traditional Chinese medicine external therapies, or physical therapy, with topical medications being the first-line treatment. However, in practical application, the following drawbacks exist:

[0004] ① Currently, there are no approved shampoo formulations for androgenetic alopecia: All topical medications for hair growth are applied topically, not in shampoo form. The only approved topical medications for androgenetic alopecia are minoxidil (tincture, lotion, foam, spray, gel), compound syatan hair growth solution (tincture, oil), compound ginseng resorcinol lotion, and ginseng and angelica hair growth tincture. ② Currently, none of the approved topical shampoos promote hair growth: The only approved shampoos are ketoconazole shampoo, selenium sulfide shampoo, and coal tar shampoo. Their main ingredients are antifungal, anti-seborrheic, corticosteroids, and coal tar. Their efficacy and approved indications do not include any type of hair loss. ③ Currently approved topical shampoos have varying degrees of adverse reactions: Currently, only ketoconazole shampoo, selenium sulfide shampoo, and coal tar shampoo have obtained national drug approval. Adverse reactions and discomforts are listed below: Ketoconazole shampoo may cause local scalp burning, itching, irritation, oiliness or dryness, and abnormal hair texture at the application site. Selenium sulfide shampoo may cause contact dermatitis, dry hair or scalp, and hair discoloration. Coal tar shampoo may cause local irritation and photosensitivity. ④ Currently approved topical medications for treating hair loss and promoting hair growth have varying degrees of adverse reactions and inconveniences: Minoxidil (tincture, lotion, spray, foam, gel): 1 mL each time, not exceeding 2 mL daily, applied to the affected area of ​​the scalp and massaged for 3-5 minutes. Adverse reactions may include mild scalp dermatitis, scalp irritation (stirring, burning, itching, dryness, folliculitis), facial hirsutism, temporary hair loss, hair color change, abnormal hair texture, headache, neuritis, dizziness, vertigo, edema, and changes in blood pressure. For Re-Fever Siyadan Hair Growth Solution (tincture, oil), apply to the hair loss area and massage for 2-3 minutes, 2-3 times a day. Adverse reactions are not yet clear. For Re-Fever Ginseng Resorcinol Tincture, apply the solution evenly to the affected area and massage for several minutes, 3-5 times a day. Adverse reactions are not yet clear. For Ginseng and Angelica Hair Growth Tincture, apply 3-6 mL to the hair loss area, 3 times a day. Adverse reactions are not yet clear.

[0005] Traditional Chinese medicine (TCM) possesses unique advantages and clinical translational potential in the treatment of hair loss. External TCM applications primarily focus on dispelling wind and dampness and promoting blood circulation. TCM shampoos, while improving symptoms, offer advantages such as fewer side effects, better patient compliance, and a stronger willingness to use them long-term, making them an attractive research and development direction. However, there are few reports on TCM shampoos for treating androgenetic alopecia.

[0006] In summary, how to provide a traditional Chinese medicine shampoo for treating androgenetic alopecia and its application is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0007] In view of this, the present invention provides a topical traditional Chinese medicine composition for promoting hair growth, relieving itching and controlling oil production, and its application.

[0008] The herbal composition shampoo of this invention is derived from a traditional Chinese medicine external wash formula used clinically to treat androgenetic alopecia. Concentrated herbal extracts are added to a basic shampoo to obtain the herbal composition shampoo. As a topical shampoo formulation, it can be directly applied to cleanse the scalp and hair, and also has certain therapeutic effects.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A topical traditional Chinese medicine composition for promoting hair growth, relieving itching, and controlling oil production includes the following components in parts by weight: 10-50 parts of Salvia miltiorrhiza, 10-30 parts of Angelica sinensis, 10-30 parts of Rosa rugosa, 10-40 parts of Mentha haplocalyx, 10-25 parts of Morus alba root bark, 10-50 parts of Dictamnus dasycarpus root bark, 10-50 parts of Eclipta prostrata, 10-40 parts of Polygonum multiflorum, 10-30 parts of Camellia sinensis seed cake, 15-50 parts of Zingiber officinale, 20-60 parts of Gleditsia sinensis, 10-40 parts of Phyllanthus emblica, and 10-32 parts of Morus alba leaf.

[0011] Furthermore, a topical Chinese medicine composition for promoting hair growth, relieving itching, and controlling oil production includes the following components in parts by weight: 15 parts of Salvia miltiorrhiza, 20 parts of Angelica sinensis, 10 parts of Rosa rugosa, 10 parts of Mentha haplocalyx, 10 parts of Morus alba root bark, 20 parts of Dictamnus dasycarpus root bark, 15 parts of Eclipta prostrata, 20 parts of Polygonum multiflorum, 30 parts of Camellia sinensis seed cake, 15 parts of Zingiber officinale, 50 parts of Gleditsia sinensis, 40 parts of Phyllanthus emblica, and 20 parts of Morus alba leaf.

[0012] The above-mentioned traditional Chinese medicine composition is used in the preparation of hair loss prevention and treatment shampoo.

[0013] Furthermore, the hair loss described is androgenetic alopecia.

[0014] Furthermore, it is used to promote hair growth, relieve itching, and control oil production.

[0015] Furthermore, the promotion of hair growth refers to improving the sum of hair diameters, total number of hairs, average hair diameter, hair density, terminal hair density, and terminal hair ratio.

[0016] Furthermore, the anti-itch and oil-control measures improve scalp dandruff scores, scalp oiliness scores, and scalp itching scores.

[0017] A shampoo for preventing and treating hair loss is prepared by combining the above-mentioned herbal extract with a shampoo base.

[0018] The herbal composition shampoo of this invention is derived from a traditional Chinese medicine external wash formula used clinically to treat androgenetic alopecia. Its dosage form (a solution containing a small amount of herbal residue with poor foaming) has been improved into a topical shampoo / hair wash. The shampoo is prepared using conventional materials and processes, by adding concentrated herbal extract to a base shampoo to obtain the herbal composition shampoo.

[0019] Application scope of traditional Chinese medicine composition lotion:

[0020] 1) Used to treat androgenetic alopecia, promote hair growth, increase hair density and total hair diameter, and improve symptoms such as itching, oiliness and dandruff.

[0021] 2) When used in combination with conventional treatment regimens for androgenetic alopecia containing minoxidil (regardless of dosage form), the incidence of adverse reactions can be reduced.

[0022] Terminology Explanation:

[0023] Androgenetic alopecia: The most common type is non-scarring alopecia, characterized by progressive miniaturization of hair follicles, caused by both genetics and androgens, manifested as a receding hairline and thinning hair on the crown.

[0024] Non-scarring alopecia: The phenomenon of hair loss exceeding the normal physiological metabolism (50-100 hairs per day), leading to thinning hair or baldness, without irreversible damage to the hair follicles. Clinically common types include androgenetic alopecia, telogen effluvium (postpartum alopecia), alopecia areata, chemotherapy-induced alopecia, and syphilitic alopecia.

[0025] Seborrheic dermatitis: a common chronic dermatitis that occurs in areas rich in sebaceous glands (such as the scalp) and is characterized by erythema, oily scaling, and itching.

[0026] Lotion: A liquid preparation specifically for use on the skin or scalp, typically used for cleaning, applying medication, or care.

[0027] External shampoo / hair wash: The medication is added to the shampoo base to provide a therapeutic effect while cleaning the scalp.

[0028] Tincture: A topical liquid preparation made by dissolving a drug in an alcohol solution.

[0029] Liniment: A topical liquid preparation specifically designed for rubbing and application, which may contain analgesic, anti-inflammatory, or skin-irritating medications.

[0030] Foaming agents: Topical preparations that form drugs into foam form, making them easy to apply, visually appealing, and less prone to dripping.

[0031] Spray: A dosage form that sprays the medicine in a mist form. It is convenient to use and can be used on large areas or areas that are difficult to reach.

[0032] Gel: A semi-solid preparation consisting of a drug and a gel matrix, which is transparent, refreshing and non-greasy.

[0033] Oil-based preparations: Dosage forms made by dissolving or mixing drugs in oils and fats, used for lubrication, protection, or treatment.

[0034] Basic and specific classification (BASP): A general and detailed method for classifying hair loss, which accurately classifies male and female hair loss by combining basic and specific types.

[0035] Baihui (GV20): An important acupoint on the Du meridian of the human body, located at the intersection of the midline of the head and the line connecting the tips of both ears.

[0036] Sum of hair diameters per unit area (μm): The sum of the diameters of all hairs within a unit area of ​​the scalp; this is an important indicator for assessing the total amount of hair growth. (Sum of hair diameters per unit area μm = Total number of hairs per unit area × Average hair diameter μm)

[0037] Total number of hairs (roots): The total number of all hairs growing in a specific observation area or on the entire scalp.

[0038] Average hair diameter (µm): The average diameter of all hairs within the observation area.

[0039] Hair density (roots / cm) 2 ): The number of hairs growing on a unit area of ​​scalp (square centimeters).

[0040] Final hair density (roots / cm) 2 ): The number of terminal hairs with a diameter ≥30µm per unit scalp area.

[0041] Final hair percentage (%): The percentage of final hairs with a diameter ≥30µm out of the total number of hairs.

[0042] Allergic reaction: An excessive immune response that occurs when the body is exposed to the same allergen again, which may manifest as rashes, itching, redness and swelling.

[0043] Adverse events: Any unexpected medical event that occurs after using the medication or receiving treatment, which is not necessarily causally related to the treatment.

[0044] Skin patch test: A skin test for diagnosing contact allergens. The suspected allergen is applied to the skin and the reaction is observed. The skin is observed repeatedly at 24 hours, 72 hours or even longer after removal to determine whether the skin has a delayed type IV allergic reaction to a certain substance.

[0045] Degree of telangiectasia: This refers to the severity assessment of the number, density, color, and morphology (e.g., linear, stellate, spiderweb-like) of persistently dilated small blood vessels (capillaries, venules, or arterioles) visible on the skin or mucous membrane surface. Doctors observe this with the naked eye or using a dermatoscope and perform a semi-quantitative grading: 0 points - none, 1 point - mild, 2 points - moderate, 3 points - severe.

[0046] Visual Analogue Scale (VAS) scoring: A tool for measuring subjective feelings (such as the degree of pain or itching). It is usually marked on a 10cm line, with the line from left to right (from 0 to 10) indicating the degree of severity. Patients are asked to draw an "×" according to the location of their perceived severity.

[0047] The Dermatology Quality of Life Index (DLQI) is a simple, effective, and widely used questionnaire used to quantify the impact of skin diseases on patients' quality of life.

[0048] As can be seen from the above technical solution, compared with the prior art, the beneficial effects achieved by the present invention are as follows:

[0049] (1) The main active ingredients of the lotion involved in this invention are all derived from traditional Chinese medicine and do not contain chemical drugs. The formulation and proportion of this traditional Chinese medicine have not been publicly reported, and this invention has the innovation of drug formulation.

[0050] (2) The shampoo involved in this invention can promote hair growth in patients with androgenetic alopecia, and no adverse reactions were found in clinical trials. Currently, there are no approved shampoo formulations for androgenetic alopecia or to promote hair growth, and none of the approved shampoo formulations have an indication for hair loss. This invention is innovative in its combination of dosage form and indication (effective when used alone).

[0051] (3) The shampoo involved in this invention, when used in combination with conventional clinical treatment regimens for androgenetic alopecia, can improve terminal hair density and proportion, and reduce patients' hair loss scores, itching scores, and oiliness scores. Currently marketed drugs or daily chemical shampoos do not provide clinical trial data to show that combined use can improve efficacy and effectively reduce adverse reactions of conventional treatment regimens. This invention has innovative clinical application scenarios (combined use with conventional treatment can increase efficacy and reduce adverse reactions caused by conventional treatment, with adverse reactions mainly originating from the topical drug minoxidil). Attached Figure Description

[0052] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0053] Figure 1 This is a drug-component-target network diagram in Example 4 of the present invention, where A represents the main active ingredient target and the target related to androgenetic alopecia, and B represents the main active ingredient-target network (main active ingredient: circle, target: purple rhombus, connection: the relationship between the drug active ingredient and the gene related to androgenetic alopecia).

[0054] Figure 2 This is the gene expression matrix of a patient with androgenetic alopecia in Example 4 of the present invention;

[0055] Figure 3 This is a schematic diagram of the BASP classification of androgenetic alopecia in Experiment 1 of this invention;

[0056] Figure 4 This is a schematic diagram of the skin allergy reaction detection of the traditional Chinese medicine composition lotion in Experiment 1 of the present invention;

[0057] Figure 5 This is a graph showing the degree of vasodilation in 10 female volunteers with androgenetic alopecia in Experiment 1 of this invention;

[0058] Figure 6 The figure shows the effectiveness index results of 10 female androgenetic alopecia volunteers in Experiment 1 of this invention. In the figure, A is the sum of hair diameter, B is the total number of hairs, C is the average hair diameter, D is the hair density, E is the terminal hair density, and F is the terminal hair ratio.

[0059] Figure 7 This is a macroscopic and microscopic (20×) schematic diagram of hair follicles in female androgenetic alopecia volunteers in Experiment 1 of this invention;

[0060] Figure 8 This refers to the Skin Quality of Life Index questionnaire used in Experiment 2 of this invention.

[0061] Figure 9 The image shows the baseline data of 25 female androgenetic alopecia patients in Experiment 2 of this invention. In the figure, A is age, B is age of onset, C is disease duration, D is family history of hair loss, E is the proportion of BASP single type and complex type, and F is BASP classification.

[0062] Figure 10 This is a scoring chart of the degree of capillary dilation in 25 pairs of female androgenetic alopecia patients in Experiment 2 of this invention;

[0063] Figure 11 The image shows the results of hair microscopic analysis of 25 female androgenetic alopecia patients in Experiment 2 of this invention. In the figure, A is the sum of hair diameter, B is the total number of hairs per unit area, C is the average hair diameter, D is the hair density, E is the terminal hair density, and F is the terminal hair ratio.

[0064] Figure 12 This is a macroscopic and microscopic (20×) schematic diagram of hair follicles in 25 pairs of female androgenetic alopecia patients in Experiment 2 of this invention;

[0065] Figure 13 The image shows the clinical symptom and sign scores of 25 pairs of female androgenetic alopecia patients in Experiment 2 of this invention. In the image, A represents hair loss score, B represents scalp scaling score, C represents scalp oiliness score, and D represents scalp itching score.

[0066] Figure 14 This is a DLQI score chart of 25 pairs of female androgenetic alopecia patients in Experiment 2 of this invention. Detailed Implementation

[0067] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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.

[0068] The reagents required for this invention are conventional experimental reagents, purchased from commercially available channels; the experimental methods not mentioned are conventional experimental methods, and will not be described in detail here.

[0069] Example 1

[0070] A topical traditional Chinese medicine composition for promoting hair growth, relieving itching, and controlling oil production.

[0071] The specific components are as follows:

[0072] Salvia miltiorrhiza 10g, Angelica sinensis 10g, Rosa rugosa 10g, Mentha haplocalyx 10g, Morus alba root bark 10g, Dictamnus dasycarpus root bark 10g, Eclipta prostrata 10g, Polygonum multiflorum 10g, Camellia japonica 10g, Zingiber officinale 15g, Gleditsia sinensis 20g, Phyllanthus emblica 10g, Morus alba leaf 10g.

[0073] Example 2

[0074] A topical traditional Chinese medicine composition for promoting hair growth, relieving itching, and controlling oil production.

[0075] The specific components are as follows:

[0076] Salvia miltiorrhiza 50g, Angelica sinensis 30g, Rosa rugosa 30g, Mentha haplocalyx 40g, Morus alba root bark 25g, Dictamnus dasycarpus root bark 50g, Eclipta prostrata 50g, Polygonum multiflorum 40g, Camellia japonica seed cake 30g, Zingiber officinale 50g, Gleditsia sinensis 60g, Phyllanthus emblica 40g, Morus alba leaf 32g.

[0077] Example 3

[0078] A topical traditional Chinese medicine composition for promoting hair growth, relieving itching, and controlling oil production.

[0079] The specific components are as follows:

[0080] Salvia miltiorrhiza 15g, Angelica sinensis 20g, Rosa rugosa 10g, Mentha haplocalyx 10g, Morus alba root bark 10g, Dictamnus dasycarpus root bark 20g, Eclipta prostrata 15g, Polygonum multiflorum 20g, Camellia japonica 30g, Zingiber officinale 15g, Gleditsia sinensis 50g, Phyllanthus emblica 40g, Morus alba leaf 20g.

[0081] Example 4

[0082] Pharmacology of Traditional Chinese Medicine Combinations

[0083] This formula is based on the holistic concept and syndrome differentiation and treatment principles of traditional Chinese medicine, with the key point of balancing Yin and Yang. It is a summary of more than ten years of clinical experience combined with modern pharmacological research.

[0084] 1) Analysis of Traditional Chinese Medicine Pharmacology

[0085] Angelica sinensis is sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It has the effect of nourishing and activating blood circulation. Salvia miltiorrhiza cools the blood, eliminates carbuncles, clears the heart, and relieves irritability. Both treat the blood aspect, working together to nourish, activate, and cool the blood. Polygonum multiflorum is slightly sweet and bitter in taste, and enters the heart, liver, and kidney meridians. It has the effects of nourishing the liver and kidneys, replenishing essence and blood, blackening hair, and reducing turbidity and lipids. Eclipta prostrata is sweet and sour in taste, cold in nature, and enters the liver and kidney meridians. It has the effects of nourishing the liver and kidneys, cooling the blood and stopping bleeding, strengthening teeth, and blackening hair. Both treat the liver and kidneys by using color to treat color, working together to blacken hair. Dictamnus dasycarpus is bitter and cold in nature, and enters the spleen, stomach, and bladder meridians. It has the effects of clearing heat and drying dampness, dispelling wind, and relieving itching. Morus alba is sweet and cold in nature, and enters the lung meridian. It has the effects of dispelling wind, activating blood circulation, and removing blood stasis. Both work together to dispel wind and relieve itching. Rose petals have a sweet and slightly bitter taste, are warm in nature, and enter the liver and spleen meridians. They have the effects of regulating qi and relieving depression, harmonizing blood and dispersing blood stasis. Peppermint has a pungent and cool taste, enters the lung and liver meridians, and has the effects of dispersing wind-heat, clearing the head and eyes, and resolving dampness. Both are aromatic, working together to promote qi circulation and blood flow. The combined effects of these herbs are to dispel wind and relieve itching, nourish blood and moisturize dryness, cool blood and promote blood circulation, and tonify the liver and kidneys, perfectly aligning with the principles of treating hair loss caused by dandruff. The excipient in this formula is tea seed cake, which contains tea saponins and natural tea oil. Long-term use can remove dandruff, relieve itching, control oil, and promote hair growth and darkening, making it a natural cleanser.

[0086] 2) Modern pharmacological analysis

[0087] Angelica sinensis water extract can significantly promote hemoglobin and erythrocyte production, improve microcirculation, and reduce inflammation. Polygonum multiflorum can promote hematopoiesis, has anti-aging, antibacterial, and immune-enhancing effects. Salvia miltiorrhiza can improve microcirculation, dilate blood vessels, relieve pain, reduce inflammation, and reduce allergies. Eclipta prostrata can enhance non-specific immune function, eliminate oxygen free radicals to inhibit 5-lipoxygenase, reduce inflammation and pain, promote hair growth, and has antibacterial effects. Mentha haplocalyx can dilate skin capillaries, reduce inflammation and itching, reduce irritation, and fight pathogenic microorganisms. Dictamnus dasycarpus bark water extract can inhibit various fungi, reduce inflammation, and reduce allergies. Morus alba bark can reduce inflammation, regulate immunity, and has antioxidant properties. Pharmacological analysis shows that this herbal combination can reduce sebum secretion, reduce inflammation, fight microorganisms, resist oxidative damage, dilate skin capillaries, improve microcirculation, and promote hair growth.

[0088] 3) Network pharmacology analysis

[0089] The active ingredients of Angelica sinensis, Polygonum multiflorum, Salvia miltiorrhiza, Eclipta prostrata, Rosa rugosa, Mentha haplocalyx, Camellia japonica seed cake, Dictamnus dasycarpus root bark, and Morus alba root bark were downloaded from the TCMSP database (https: / / www.tcmsp-e.com / # / home). The active ingredients were obtained by setting an OB value greater than or equal to 30% and a DL value greater than or equal to 0.2 as thresholds.

[0090] The target and interaction files for the corresponding active ingredients were downloaded from the Pubchem database (https: / / pubchem.ncbi.nlm.nih.gov / ) and compiled into the corresponding files. A total of 4593 targets for the active ingredients were identified. KEGG and GO enrichment analyses were performed on these 4593 target genes. KEGG analysis revealed that the pathways and metabolic pathways involved by the target genes mainly fall into the following categories: cancer-related pathways, signal transduction pathways, drug resistance pathways, infectious disease pathways, cellular process pathways, chemical carcinogenic pathways, and metabolic pathways. Signal transduction pathways include the MAPK signaling pathway, TNF signaling pathway, p53 signaling pathway, HIF-1 signaling pathway, and FoxO signaling pathway. Apoptosis, cell cycle, and cellular senescence belong to cellular process pathways. Furthermore, chemical carcinogenic pathways are related to receptor activation and reactive oxygen species, while metabolic pathways include lipids and atherosclerosis, directly associated with metabolic processes.

[0091] GO analysis revealed that these biological processes (BP), cellular composition (CC), and molecular functions (MF) reflect the diverse response mechanisms of cells to external environmental stimuli, chemical substances, and oxidative stress. In biological processes, cells regulate glandular development, apoptosis signaling pathways, and steroid metabolism by sensing and responding to factors such as nutrient levels, exogenous stimuli, and oxygen concentration. Furthermore, cells respond to internal and external stimuli such as oxidative stress and steroid hormones, regulating intrinsic apoptosis signaling pathways. Regarding cellular composition, structures such as focal adhesions, cell-matrix junctions, chromosomal regions, and vesicle cavities are involved, playing crucial roles in signal transduction, substance transport, and gene regulation. In terms of molecular function, cells regulate gene expression, protein phosphorylation, and redox reactions through mechanisms such as the binding of specific transcription factors, protein kinase activity, and antioxidant activity, ensuring cellular homeostasis under complex physiological and pathological conditions.

[0092] Then, 152 genes related to androgenetic alopecia were downloaded from the Genecards database (https: / / www.genecards.org / ) with a relevance score greater than 10 as the threshold. The intersection of the active ingredient target and androgenetic alopecia genes was then used to obtain 96 androgenetic alopecia targets corresponding to the active ingredient. Figure 1 A), then obtain the drug component file (supplementary3) corresponding to the target, and use Cytoscape software to draw the drug-component-target network diagram ( Figure 1 B).

[0093] The androgenetic alopecia microarray GSE68801 was downloaded from the GEO database. Gene expression matrices were extracted from normal samples (n=36) and disease samples (n=60). Normal samples were used as the control group, and disease samples as the treatment group. Differential analysis was performed using LOG2 FC absolute value > 0.585 and FDR value < 0.05 as thresholds. 497 genes were upregulated, and 430 genes were downregulated. Among the upregulated genes, CXCL10, AKR1C3, and CCL2 were identified as androgenetic alopecia-related targets of the active ingredient. Figure 2 (Table 1).

[0094] Table 1. Drugs and active ingredients corresponding to CXCL10, AKR1C3, and CCL2.

[0095]

[0096] Example 5

[0097] Preparation of Traditional Chinese Medicine Composition Lotion

[0098] Includes the following steps:

[0099] (1) Alcohol extraction

[0100] The above-mentioned medicinal materials were selected to be free of impurities, dried, and mechanically crushed. 500 g of coarse particles were weighed according to the prescription and placed in a round-bottom flask. Five times the amount of 70% ethanol was added, and the mixture was soaked for 4-6 hours. The round-bottom flask containing the soaked medicinal materials was fixed on a reflux evaporator and extracted by reflux at 80-90°C for 2 hours. The extract was filtered through an 80-mesh sieve, and the resulting extract was transferred to a rotary evaporator and concentrated under reduced pressure at 60°C to one-third of the weight of the raw medicinal materials, yielding ethanol extract A, which was then set aside.

[0101] (2) Water extraction

[0102] Pure water was added to the residue after alcohol extraction in a round-bottom flask. The first extraction used 5 times the amount of water, and the second used 3 times the amount of water. Extraction was performed twice at 100°C for 1 hour each time, using the same apparatus. The extracts were filtered through an 80-mesh sieve, and the extracts were combined. The filtered extract was transferred to a rotary evaporator and concentrated under reduced pressure at 80°C to 3 times the weight of the raw medicinal material, yielding aqueous extract B, which was then set aside.

[0103] (3) Combining the extracts

[0104] Combine the alcohol extract A and the water extract B, add water to a final volume of 2000 mL, stir well, and filter through a 200-mesh sieve to obtain the herbal extract.

[0105] (4) Preparation of traditional Chinese medicine composition lotion

[0106] Preservatives can be added to the above-mentioned Chinese herbal extracts.

[0107] Experiment 1

[0108] Ten female volunteers with androgenetic alopecia were recruited from the public for safety assessment. Subsequently, their existing shampoo was replaced with the herbal composition shampoo prepared according to the formula of Example 3 and the method of Example 5. The shampoo was used continuously for 12 weeks, and a control group was formed before the intervention to evaluate its safety and efficacy. The specific research protocol and results are as follows:

[0109] (1) Research subjects

[0110] Ten female volunteers with androgenetic alopecia recruited from the public were selected as research subjects. They voluntarily participated in the clinical study, signed informed consent forms, and were included after being assessed and screened by physicians at the associate chief physician level or above.

[0111] (2) Western medicine diagnostic criteria

[0112] According to the diagnostic criteria for female-type androgenetic alopecia in *Chinese Clinical Dermatology*, edited by Professor Zhao Bian: 1) Gradual thinning of hair on the crown, with a remaining hairline on the forehead, and scalp hair remaining on the occipital region and temples, with fine vellus hair visible; no skin atrophy. 2) Excessive scalp oil, greasy hair, or significant dandruff accompanied by itching. 3) Meets the Basic and Specific Classification (BASP) criteria. Figure 3 4) There are family members with similar hair loss symptoms. 5) It is often accompanied by menstrual abnormalities, infertility, increased body hair, acne, obesity, etc.

[0113] (3) Traditional Chinese Medicine Diagnostic Criteria

[0114] According to the diagnostic criteria for hair loss (i.e., androgenetic alopecia in Western medicine) in "Traditional Chinese Medicine Dermatology and Venereology" edited by Professor Yang Zhibo: 1) Blood-heat and wind-dryness syndrome: Dry, slightly yellowish hair, evenly and sparsely falling out, white flakes flying when scratched, and growing back after falling off; feeling hot in the head and itchy scalp; red tongue with thin yellow coating, and thready and rapid pulse. 2) Blood-deficiency and wind-dryness syndrome: Long-term hair loss, sparse hair, dry and yellow, scalp with scaly patches, itching, accompanied by pale complexion, dizziness, palpitations, and possibly fatigue; pale tongue with thin coating, and thready pulse. 3) Spleen and stomach damp-heat syndrome: Mostly those who habitually indulge in rich and greasy foods; damp hair, as if oiled or soaked in water, sometimes with several hairs stuck together, greasy scales; red tongue with slightly greasy yellow coating, and soft and rapid pulse. 4) Liver and kidney deficiency syndrome: Usually dry and brittle hair, and when the disease occurs, large patches of hair often fall out evenly; accompanied by pale complexion, cold limbs and aversion to cold, dizziness and tinnitus, soreness and weakness of the waist and knees; pale red tongue with little or no coating, and deep, thready and weak pulse.

[0115] (4) Inclusion criteria

[0116] 1) The disease meets the diagnostic criteria for androgenetic alopecia mentioned above (meeting either the Western medicine diagnostic criteria or the traditional Chinese medicine diagnostic criteria is sufficient); and the patient is a mild / moderate case according to the BASP classification, including M1 and M2, C1, V1 and V2, F1, F2 and F3 types. 2) Female, aged 18-50 years. 3) The patient has not taken or used any topical medications for hair loss in the 6 months prior to enrollment; and agrees not to change their treatment plan during this study. 4) The patient voluntarily participates in this study, is willing to accept the experimental drug treatment, and signs an informed consent form.

[0117] (5) Exclusion criteria

[0118] 1) Patients with congenital alopecia, cicatricial alopecia, lupus alopecia, syphilitic alopecia, trichotillomania, and other cicatricial alopecia; patients with severe diffuse alopecia; patients with concurrent scalp soft tissue infections, tinea capitis, or alopecia areata; patients who have undergone hair transplantation; and patients with extremely poor prognosis due to alopecia caused by drugs, trauma, physical and chemical factors, other systemic diseases, or tumors. 2) Patients with local skin diseases that affect trichomicroscopic examination, such as seborrheic dermatitis. Patients currently undergoing treatment for severe circulatory, digestive, endocrine, nervous, or immune system-related diseases, or whose condition is unstable. 3) Pregnant, lactating, or women planning pregnancy.

[0119] (6) Exit (Shedding) Standards

[0120] 1) Those who develop other illnesses requiring treatment during the observation period and are forced to terminate the trial. 2) Those who discover an allergic reaction to the medication used in this trial after administration and are unable to continue the trial. 3) Those who fail to adhere to treatment or refuse to cooperate with treatment; those whose data is incomplete and affects statistical analysis. 4) Those who become pregnant during the trial period.

[0121] (7) Grouping and control

[0122] Ten study participants were grouped together, and data from week 12 of the intervention were compared with baseline data before the intervention.

[0123] (8) Intervention measures

[0124] The herbal composition shampoo of this invention was used to replace the participants' original shampoo. Depending on hair volume, 5-15 mL was applied evenly to all areas of the scalp, lathered, and massaged for 1-2 minutes before rinsing with water. The shampoo was used once every 1-3 days for 12 consecutive weeks.

[0125] (9) Observation indicators

[0126] 1) Safety indicators

[0127] a. Allergic reaction. The undiluted lotion was applied to the inner forearm of each of the 10 study participants, covering an area of ​​approximately 4 × 6 cm. 2 Leave on for 30 minutes, then wash off. Observe the application area and surrounding area for any allergic reactions such as redness or itching. Follow up one week later to check for any special discomfort in the local area or throughout the body.

[0128] b. Adverse Events. Adverse medical events occurring after a participant signs up to participate in this clinical study and receives the medication may manifest as symptoms and signs (including local scalp allergies and systemic allergic reactions), diseases, or abnormal laboratory tests, but are not necessarily causally related to the investigational drug. Any local or systemic discomfort experienced by a participant during the study will be assessed by a physician with a senior professional title or above to determine whether the adverse reaction is related to the treatment drug and to provide management recommendations.

[0129] c. Hair microscopy evaluation criteria (Foto Finder body studio ATBM digital dermoscopy, evaluation image magnification is 20x, hair analysis is performed at Baihui acupoint): degree of capillary dilation (0 points - none, 1 point - mild, 2 points - moderate, 3 points - severe).

[0130] 2) Effectiveness indicators

[0131] The evaluation criteria for dermoscopy (Foto Finder body studio ATBM digital dermoscopy, evaluation image magnification 20x, analysis image magnification 50x, area per field of view approximately 0.238cm²) are as follows: 2 Hair analysis was performed at Baihui acupoint based on the BASP classification of both groups of patients: a. Sum of hair diameters (µm); b. Total number of hairs (roots); c. Average hair diameter (µm); d. Hair density (roots / cm²). 2 e. Final hair density (hair / cm²) 2 f. Final hair percentage (%).

[0132] Table 2 Follow-up period and observation indicators

[0133]

[0134] (10) Research Results

[0135] 1) General Information

[0136] The 10 female volunteers with androgenetic alopecia ranged in age from 24 to 40 years, with an age of onset of 15 to 34 years and a disease duration of 18 (6, 33) months. 50% (5 / 10) had a family history of alopecia. According to the BASP classification, 4 cases were LF1, 4 cases were M1F1, 1 case was C1F1, and 1 case was LF2.

[0137] 2) Security Data

[0138] At the start of the study, a skin patch test was performed to evaluate drug allergic reactions, such as... Figure 4 As shown. None of the 10 study participants experienced any skin allergic reactions (redness, swelling, itching, rash, etc.).

[0139] The capillary dilation score did not conform to a normal distribution. A Wilcoxon rank-sum test was used. The mean capillary dilation score before medication was 0.4 ± 0.66 points, and the mean capillary dilation score after medication was 0.1 ± 0.3 points. There was no statistically significant difference in capillary dilation before and after medication (p = 0.5000). See details... Figure 5 Data is presented as mean ± standard deviation (Mean ± SD).

[0140] During the 12-week intervention period, none of the 10 study participants experienced scalp itching, increased dandruff, rash, or increased hair loss, and no other adverse reactions were reported. This indicates that the herbal composition shampoo has good safety.

[0141] 3) Validity data

[0142] Ten female volunteers with androgenetic alopecia were included. The sum of hair diameter, total number of hairs per unit area, average hair diameter, hair density, terminal hair density, and terminal hair ratio all conformed to a normal distribution. Paired samples t-tests were used to compare the results before and after treatment for the same volunteer. Data are presented as mean ± standard deviation (Mean ± SD).

[0143] The sum of hair diameters was 3008.803 ± 475.52 µm before treatment and 3345.93 ± 509.59 µm after treatment (p = 0.0334), indicating that the herbal composition wash significantly improved the sum of hair diameters. Figure 6 A.

[0144] The total number of hairs per unit area was 48.36 ± 5.62 before treatment and 51.3 ± 4.17 after treatment (p = 0.0235), indicating that the herbal composition wash significantly improved hair count. Figure 6 B.

[0145] The average hair diameter was 62.88 ± 8.57 µm before treatment and 65.45 ± 10.4 µm after treatment (p = 0.1714), indicating that the herbal composition wash had no statistically significant effect on improving hair diameter. Figure 6 C.

[0146] Hair density before treatment: 153 ± 15.03 hairs / cm² 2 After treatment, the number of roots / cm was 163.53 ± 12.31. 2 The p-value was 0.0289, indicating that the traditional Chinese medicine composition lotion had a statistically significant effect on improving hair density. (See [reference needed]). Figure 6 D.

[0147] Final hair density, before treatment: 125.95 ± 13.93 hairs / cm² 2 After treatment, the number of roots / cm was 146.72 ± 14.5. 2 The p-value was 0.0048, indicating that the traditional Chinese medicine composition lotion had a statistically significant effect on improving terminal hair density. (See [reference needed]). Figure 6 E.

[0148] The percentage of terminal hair was 82.65 ± 6.82% before treatment and 89.96 ± 7.16% after treatment (p = 0.0168), indicating that the traditional Chinese medicine composition lotion significantly improved the percentage of terminal hair. Figure 6 F.

[0149] Gross appearance and hair microscopic images: No significant difference was observed in gross appearance before and after treatment. Hair microscopic images (20×) at the Baihui acupoint showed increased hair density and new hair growth after treatment. Figure 7 .

[0150] Experiment 2

[0151] Fifty female patients with androgenetic alopecia who visited our hospital's hair loss clinic were recruited and randomly assigned to groups based on age, disease duration, family history of hair loss, BASP classification, and treatment regimen. The control group received the standard treatment regimen, while the observation group received the standard treatment regimen combined with the herbal composition lotion of this invention (prepared according to the formula of Example 3 and the method of Example 5), for 12 weeks. The safety and clinical efficacy of the herbal composition lotion were observed in a real clinical setting. The specific research protocol and results are as follows:

[0152] (1) Study subjects: Fifty female patients with androgenetic alopecia who visited the Department of Dermatology of the Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine from February 2024 to December 2024 were selected as study subjects. They voluntarily participated in the clinical study, signed informed consent forms, and were included after being assessed and screened by physicians at the deputy director level or above.

[0153] (2) Western medicine diagnostic criteria: same as Experiment 1.

[0154] (3) Traditional Chinese medicine diagnostic criteria: same as Experiment 1.

[0155] (4) Inclusion criteria: Same as Experiment 1.

[0156] (5) Exclusion criteria: Same as Experiment 1.

[0157] (6) Exit (detachment) criteria: Same as Experiment 1.

[0158] (7) Grouping and Matching

[0159] Study participants were recruited and matched from female patients with androgenetic alopecia who visited our hair loss clinic. Matching factors included age, disease duration, family history of hair loss, BASP classification, and strict matching of treatment regimens. Matched pairs of participants were randomly assigned to either the control group or the observation group, with a 1:1 ratio of participants in each group.

[0160] (8) Intervention measures

[0161] During the treatment period, both groups of patients were advised to avoid overexertion, relax, eat a light diet, avoid staying up late, and get regular rest.

[0162] 1) Control group: The physician adopted a comprehensive treatment plan based on the patient's actual condition (refer to the "Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia in China"). The comprehensive treatment plan included oral medications: spironolactone tablets (National Drug Approval Number H20093097), compound glycyrrhizin tablets (National Drug Approval Number H20093006), tanshinone capsules (National Drug Approval Number Z13020110), etc.; topical medications: minoxidil lotion (Dafeixin 2%, National Drug Approval Number: H20020190), compound syatan hair growth tincture (National Drug Approval Number Z65020167), etc., as well as microneedling, low-energy laser, concentrated growth factors, etc.

[0163] 2) Observation group: In addition to the same actual treatment plan as the control group, a traditional Chinese medicine composition shampoo was added. The traditional Chinese medicine composition shampoo replaced the patient's original shampoo. 5-15 mL was used each time, depending on the hair volume, and evenly applied to all parts of the scalp. After lathering, the patient massaged for 1-2 minutes and then rinsed with water. The shampoo was used once every 1-3 days for 12 consecutive weeks.

[0164] (9) Observation indicators

[0165] 1) Safety indicators

[0166] Adverse events. Adverse medical events occurring after a participant signs up to participate in this clinical study and receives the medication may manifest as symptoms and signs (including local scalp allergies and systemic allergic reactions), diseases, or abnormal laboratory tests, but are not necessarily causally related to the investigational drug. Any local or systemic discomfort experienced by a participant during the study will be assessed by a physician with a senior professional title or above to determine whether the adverse reaction is related to the treatment drug and to provide management recommendations.

[0167] Hair microscopy evaluation criteria (Foto Finder body studio ATBM digital dermoscopy, evaluation image magnification is 20x, hair analysis is performed at Baihui acupoint): degree of capillary dilation (0 points - none, 1 point - mild, 2 points - moderate, 3 points - severe).

[0168] 2) Effectiveness indicators

[0169] ① Trichoscopy Evaluation Criteria (Foto Finder body studio ATBM digital dermoscopy, evaluation image magnification 20x, analysis image magnification 50x, area per field of view approximately 0.238cm²) 2 Hair analysis was performed at Baihui acupoint based on the BASP classification of both groups of patients: a. Sum of hair diameters (µm); b. Total number of hairs (roots); c. Average hair diameter (µm); d. Hair density (roots / cm²). 2 e. Final hair density (hair / cm²)2 f. Final hair percentage (%).

[0170] ② Clinical symptom and sign scoring: All scores were completed the day after shampooing: a. Hair loss score; b. Scalp dandruff score; c. Scalp oiliness score. A 4-point scoring method was used, and the patient self-assessed the score. d. Scalp itching score: A numerical rating scale (NRS) was used. A straight line from left to right (from 0 to 10) represents the increasing severity of itching. Patients marked "×" according to the location of their perceived itching level. The patient self-assessed the score.

[0171] The scoring details are as follows:

[0172] a. Hair loss score

[0173] 0 points: Daily hair loss <50 strands;

[0174] 2 points: 50 < Daily hair loss < 100 strands;

[0175] 4 points: 100 hairs < daily hair loss < 150 hairs;

[0176] 6 points: Daily hair loss >150 strands.

[0177] b. Scalp dandruff score (the day after shampooing)

[0178] 0 points: No scales;

[0179] 2 points: A small amount of scales, which can only be removed by scratching vigorously;

[0180] 4 points: Numerous flaky scales that fall off easily when the hair is gently moved;

[0181] 6 points: A large amount of scales, which fall off easily when the head is shaken.

[0182] c. Scalp oiliness rating (the day after shampooing)

[0183] 0 points: Not greasy, only becomes greasy after three days without washing;

[0184] 2 points: Slightly oily; becomes oily again after two days without washing.

[0185] 4 points: It's quite oily; it gets quite oily if you don't wash it for a day.

[0186] 6 points: Very greasy, still feels greasy even after washing once a day.

[0187] d. Scalp itching score (day after shampooing)

[0188]

[0189] ③ Dermatology Quality of Life Assessment Standard (DLQI Score): The DLQI scale contains 10 questions, with a total score of 30 points. This scale is self-assessed by the patient. For details of the Dermatology Quality of Life Index questionnaire, please refer to [link to questionnaire]. Figure 8 The scoring details are as follows:

[0190] Very many 3 points; many 2 points; a little 1 point; none at all 0 points; irrelevant 0 points; Question 7, "yes" 3 points.

[0191] The degree of impact on quality of life is divided into 5 levels: 0-1 points: no impact on the patient's quality of life at all; 2-5 points: slight impact on the patient's quality of life; 6-10 points: moderate impact on the patient's quality of life; 11-20 points: significant impact on the patient's quality of life; 21-30 points: serious impact on the patient's quality of life.

[0192] Table 3 Follow-up period and observation indicators

[0193]

[0194] (10) Research Results

[0195] After baseline data and treatment plan matching, 25 pairs of female androgenetic alopecia patients were included in the control group and observation group. All patients signed informed consent forms and completed 12 weeks of intervention and follow-up. All data, including medical records, trichoscopy, questionnaires, rating scales, and adverse reactions, were collected completely.

[0196] 1) General Information

[0197] The control group ranged in age from 20 to 41 years, while the observation group ranged in age from 18 to 43 years. Mann-Whitney U test analysis showed no statistically significant difference in age distribution between the two groups. See [link / reference] Figure 9 A.

[0198] The age of onset in the control group ranged from 14 to 33 years, while that in the observation group ranged from 16 to 33 years. Independent samples t-test analysis showed no statistically significant difference in the age of onset between the two groups. (See...) Figure 9 B.

[0199] The disease duration in the control group was 8 (2, 36) months, and in the observation group it was 10 (3, 35) months. Mann-Whitney U test analysis showed no statistically significant difference in disease duration between the two groups. See Figure 9 C.

[0200] The proportion of individuals with a family history of hair loss was 60% (15 / 25) in the control group and 64% (16 / 25) in the observation group. The chi-square test (χ² = 0.85) showed no statistically significant difference (p = 0.991 ≥ 0.05), indicating that the proportions of individuals with a family history of hair loss were comparable between the two groups. See [link / reference]. Figure 9D.

[0201] In the control group of 25 patients, the BASP classification showed 7 cases of F1, 2 cases of F2, 10 cases of M1F1, and 6 cases of M2F1, with a single type accounting for 36% and a complex type accounting for 64%. In the observation group of 25 patients, the BASP classification showed 11 cases of F1, 3 cases of F2, 6 cases of M1F1, and 5 cases of M2F1, with a single type accounting for 56% and a complex type accounting for 44%. The chi-square test (χ² = 2.180) showed no statistically significant difference in BASP classification between the two groups. See [link to relevant documentation]. Figure 9 E~ Figure 9 F.

[0202] There were no statistically significant differences between the control group and the observation group in terms of patient age, age of onset, disease duration, and grade / type of androgenetic alopecia; baseline data were comparable. Data are presented as mean ± standard deviation (Mean ± SD).

[0203] 2) Security Data

[0204] In the control group and the observation group, 42 patients (21 pairs) used minoxidil lotion (Dafeixin 2%, National Drug Approval Number: H20020190), and 8 patients (4 pairs) did not use minoxidil lotion.

[0205] None of the 50 patients experienced allergic reactions such as erythema or papules, and none of the 8 patients (4 pairs) who did not use minoxidil ointment experienced any adverse reactions.

[0206] In the control group, 2 patients experienced scalp itching and increased hair loss, 1 patient experienced scalp itching and increased dandruff, 1 patient experienced increased hair loss and increased dandruff, 2 patients experienced scalp itching, and 1 patient experienced increased dandruff. In the observation group, 1 patient experienced scalp itching and increased dandruff, and 2 patients experienced scalp itching. Specific comparisons of adverse reactions are shown in Table 4.

[0207] Table 4. Comparison of adverse reactions in 25 female patients with androgenetic alopecia

[0208]

[0209] The degree of capillary dilation before and after treatment was evaluated in two groups of female patients with androgenetic alopecia (n = 25 / group) using trichoscopy data. Since the capillary dilation scores did not conform to a normal distribution, the Wilcoxon rank-sum test was used for intra-group comparisons, and the Mann-Whitney U test was used for inter-group comparisons. Data are presented as mean ± standard deviation (Mean ± SD).

[0210] The capillary dilation score was as follows: Control group: 0.84 ± 0.67 points before treatment, 0.44 ± 0.5 points after treatment; Observation group: 0.88 ± 0.71 points before treatment, 0.36 ± 0.48 points after treatment. Pre-treatment inter-group comparison p = 0.9453, indicating comparability between the two groups. Post-treatment intra-group comparison: Control group p = 0.0453, Observation group p = 0.0068, both groups showed significant improvement in capillary dilation in the observed area after treatment compared to baseline. Post-treatment inter-group comparison: p = 0.7733, no statistically significant difference in improvement in capillary dilation between the two groups. (See details...) Figure 10 .

[0211] 3) Validity data

[0212] ① Hair microscopy analysis indicators

[0213] Twenty-five pairs of female patients with androgenetic alopecia (n = 25 / group) were included in two groups. The sum of hair diameter, total number of hairs per unit area, average hair diameter, hair density, terminal hair density, and terminal hair ratio all conformed to a normal distribution. Paired samples t-tests were used for comparisons within groups before and after treatment, and independent samples t-tests were used for comparisons between groups. Data are presented as mean ± standard deviation (Mean ± SD).

[0214] The sum of hair diameters was 2731.348 ± 695.71 µm before treatment in the control group and 3036.3992 ± 819.31 µm after treatment; in the observation group, it was 2696.1172 ± 724.13 µm before treatment and 2978.5516 ± 770.94 µm after treatment. The inter-group comparison before treatment was p = 0.8643, indicating comparable baselines between the two groups. The intra-group comparison after treatment was p = 0.0056 in the control group and p = 0.0024 in the observation group; the inter-group comparison after treatment was p = 0.8022. This means that both conventional treatment and conventional treatment combined with the traditional Chinese medicine composition wash could improve the sum of hair diameters, but there was no statistically significant difference in the improvement effect between the two groups. Figure 11 A.

[0215] Total number of hairs per unit area (approximately 0.238 cm² of field of view at 50x magnification). 2 In the control group, the number of hairs per unit area was 43.36 ± 10.16 before treatment and 46.84 ± 11.65 after treatment; in the observation group, the number was 44.76 ± 9.5 before treatment and 48.64 ± 8.76 after treatment. The inter-group comparison before treatment was p = 0.6243, indicating comparable baselines between the two groups. Intra-group comparison after treatment: p = 0.0153 in the control group and p = 0.005 in the observation group. Inter-group comparison after treatment: p = 0.5480. This indicates that both conventional treatment and conventional treatment combined with the traditional Chinese medicine shampoo can improve the total number of hairs per unit area, with no statistically significant difference in improvement between the two groups. Figure 11 B.

[0216] The average hair diameter was 64.7 ± 8.63 µm before treatment and 65.1 ± 9.1 µm after treatment in the control group; and 59.59 ± 9.49 µm before treatment and 60.97 ± 9.73 µm after treatment in the observation group. Before treatment, the inter-group comparison was p = 0.0568, indicating comparable baselines between the two groups. After treatment, the intra-group comparison showed p = 0.7838 in the control group and p = 0.3312 in the observation group, indicating no significant improvement from baseline in either group. The inter-group comparison showed p = 0.1370, indicating no statistically significant difference between the two groups. In other words, neither conventional treatment nor conventional treatment combined with the traditional Chinese medicine composition shampoo achieved a statistically significant difference in the average hair diameter, and there was no significant difference between the two groups. Figure 11 C.

[0217] Hair density: Before treatment, the control group had 142.88 ± 33.67 hairs / cm². 2 After treatment, the number of roots / cm was 151.36 ± 33.68. 2 Before treatment, the number of roots / cm in the observation group was 144.95 ± 32.54. 2 After treatment, the number of roots / cm was 157.73 ± 29.45. 2 Before treatment, the inter-group comparison p = 0.8295, indicating comparable baselines between the two groups. After treatment, the intra-group comparisons were: control group p = 0.0211, observation group p = 0.001; the inter-group comparisons were: p = 0.4883. This means that both conventional treatment and conventional treatment combined with the traditional Chinese medicine shampoo improved hair density, with no statistically significant difference in improvement between the two groups. (See attached image) Figure 11 D.

[0218] Final hair density: 120.17 ± 29.56 hairs / cm² in the control group before treatment. 2 After treatment, the number of roots / cm was 123.53 ± 31.52. 2 Before treatment, the number of roots / cm in the observation group was 117.14 ± 31.71. 2 After treatment, the number of roots / cm was 132.62 ± 33.24. 2 Before treatment, the inter-group comparison p = 0.7337, indicating comparable baselines between the two groups. After treatment, the intra-group comparisons were: control group p = 0.4694, observation group p = 0.001; the inter-group comparisons were: p = 0.3361. This means that conventional treatment combined with the traditional Chinese medicine composition wash can improve terminal hair density, while conventional treatment alone failed to improve terminal hair density. Figure 11 E.

[0219] The percentage of terminal hair was 83.07 ± 7.65% before treatment and 83.16 ± 8.03% after treatment in the control group; and 81.16 ± 8.75% before treatment and 85.67 ± 9.9% after treatment in the observation group. Before treatment, the inter-group comparison p = 0.4243, indicating comparable baselines between the two groups. After treatment, the intra-group comparisons were: control group p = 0.9495, observation group p = 0.0048; and the inter-group comparisons were: p = 0.3405. This indicates that conventional treatment combined with the traditional Chinese medicine composition wash can improve the percentage of terminal hair, while conventional treatment alone failed to improve it. (See [link to relevant documentation]). Figure 11 F.

[0220] Gross appearance and hair microscopic images: Both groups showed significant improvement in gross appearance after treatment. Hair microscopic images (20×) at the Baihui acupoint showed increased hair density and diameter in both groups after treatment. The improvement in terminal hair density and proportion was more significant in the observation group than in the control group. The degree of telangiectasia decreased in the observation group after treatment, while no significant change was observed in the control group. Figure 12 .

[0221] ② Clinical symptom and sign score

[0222] Twenty-five pairs of female patients with androgenetic alopecia (n = 25 / group) were included in two groups. Hair loss, scalp scaling, and scalp oiliness were scored using a 4-point scale, while scalp itching was scored using the visual analog scale. All scores were self-assessed by patients the day after shampooing. Clinical symptom scores did not conform to a normal distribution. Within-group comparisons before and after treatment were performed using the Wilcoxon rank-sum test, and between-group comparisons were performed using the Mann-Whitney U test. Data are presented as mean ± standard deviation (Mean ± SD).

[0223] Hair loss scores were compared before treatment; the inter-group p-value was 0.9998, indicating comparable baselines between the two groups. After treatment, intra-group comparisons showed p-values ​​of 0.3843 in the control group and 0.0448 in the observation group; inter-group comparisons showed p-values ​​of 0.3313. This indicates that conventional treatment combined with a traditional Chinese medicine shampoo combination can improve hair loss, while conventional treatment alone failed to improve hair loss. Figure 13 A.

[0224] Scalp scaling scores: Before treatment, the inter-group comparison p = 0.67, indicating comparable baselines between the two groups. After treatment, intra-group comparisons: control group p = 0.9749, observation group p = 0.1875; inter-group comparisons: p = 0.4149. This indicates that neither group showed significant improvement in scalp scaling. Figure 13 B.

[0225] Scalp oiliness score: Before treatment, the inter-group comparison p = 0.8522, indicating comparable baselines between the two groups. After treatment, intra-group comparison: control group p = 0.5488, observation group p = 0.0314; inter-group comparison: p = 0.6002. This indicates that conventional treatment combined with a traditional Chinese medicine shampoo can improve scalp oiliness, while conventional treatment alone fails to improve scalp oiliness. Figure 13 C.

[0226] Scalp itching scores: Before treatment, the inter-group comparison p = 0.2835, indicating comparable baselines between the two groups. After treatment, intra-group comparisons: control group p = 0.5, observation group p = 0.0024; inter-group comparisons: p = 0.399. This indicates that conventional treatment combined with the traditional Chinese medicine shampoo combination can improve scalp itching, while conventional treatment alone fails to improve scalp itching. (See...) Figure 13 D.

[0227] ③ Dermatology Quality of Life Assessment Standard (DLQI Score)

[0228] Twenty-five pairs of female patients with androgenetic alopecia (n = 25 / group) were included in two groups. DLQI scores were self-assessed by patients the day after shampooing. DLQI scores did not conform to a normal distribution. Within-group comparisons were performed using the Wilcoxon rank-sum test, and between-group comparisons were performed using the Mann-Whitney U test. Data are presented as mean ± standard deviation (Mean ± SD).

[0229] Before treatment, the inter-group comparison p = 0.9807, indicating comparable baselines between the two groups. After treatment, the intra-group comparisons were: control group p = 0.2949, observation group p = 0.0605; the inter-group comparisons were: p = 0.8499. This means that the combination of conventional treatment and the traditional Chinese medicine wash improved patients' quality of life, but the difference was not statistically significant, and there was no statistically significant difference compared to conventional treatment. (See [link to relevant documentation]). Figure 14 .

[0230] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0231] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An external use traditional Chinese medicine composition for promoting hair growth, relieving itching and controlling oil, characterized in that, The components include the following mass parts: Danshen 10-50 parts, Danggui 10-30 parts, Rose flower 10-30 parts, Mint 10-40 parts, Sangbaipi 10-25 parts, Baijianpi 10-50 parts, Moxianlian 10-50 parts, Heshouwu 10-40 parts, Chaku 10-30 parts, Shengjiang 15-50 parts, Zaokong 20-60 parts, Yuganzi 10-40 parts and Sangye 10-32 parts.

2. The external use traditional Chinese medicine composition for promoting hair growth, relieving itching and controlling oil according to claim 1, characterized in that, The components include the following mass parts: Danshen 15 parts, Danggui 20 parts, Rose flower 10 parts, Mint 10 parts, Sangbaipi 10 parts, Baijianpi 20 parts, Moxianlian 15 parts, Heshouwu 20 parts, Chaku 30 parts, Shengjiang 15 parts, Zaokong 50 parts, Yuganzi 40 parts and Sangye 20 parts.

3. Use of the traditional Chinese medicine composition of any one of claims 1 or 2 in the preparation of a lotion for preventing and treating alopecia.

4. Use according to claim 3, wherein the compound is ###0002### The alopecia is androgenetic alopecia.

5. The use according to claim 3, wherein the compound is ###0002### It is used for promoting hair growth, relieving itching and controlling oil.

6. Use according to claim 5, wherein The promoting hair growth is improving the sum of hair diameters, total number of hairs, average hair diameter, hair density, terminal hair density and terminal hair proportion.

7. The use according to claim 5, wherein the compound is ###0002### The relieving itching and controlling oil is improving the scalp scale score, scalp greasy score and scalp itching score.

8. A lotion for preventing and treating hair loss, characterized by comprising, It is prepared by combining the extract of the traditional Chinese medicine composition of any one of claims 1 or 2 with a shampoo base.

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