Androgenic alopecia
Conditions
Interventions
Traditional Chinese Medicine Group:Yishen Wufa Oral Liquid (oral administration)
Western Medicine Group:Minoxidil Tincture (topical administration)
Combined Therapy Group:Yishen Wufa Oral Liquid (oral administration)+Minoxidil Tincture (topical administration)
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for androgenetic alopecia (AGA) in Western medicine; 2) Meet the diagnostic criteria for hair loss due to liver-kidney deficiency syndrome in Traditional Chinese Medicine (TCM); 3) Patients with hair loss grade III, IV, or V according to the Hamilton-Norwood grading scale; 4) Males aged between 18 and 50 years; 5) Individuals who have signed the informed consent form and voluntarily agree to participate in the trial.
Exclusion criteria
Exclusion criteria: 1) Individuals with other hair loss diseases besides AGA, such as alopecia areata, diffuse alopecia areata, syphilis-induced alopecia, scarring alopecia, malnutrition-induced alopecia, and chemotherapy/radiotherapy-induced alopecia; 2) Individuals with scalp skin diseases that may affect efficacy evaluation, or scalp trauma, or other scalp skin lesions requiring topical treatment (e.g., fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis, scalp atrophy); 3) Individuals who used topical medications (including corticosteroids, estrogens, traditional Chinese medicine preparations, etc.) on the hair loss area for =2 consecutive weeks within 3 months prior to screening, which may interfere with efficacy evaluation; 4) Individuals who received androgen replacement therapy, immunosuppressants, or other drugs that may interfere with efficacy evaluation within 3 months prior to screening; or those who used minoxidil within 6 months prior to screening; 5) Individuals who received autologous platelet-rich plasma therapy, chemotherapy, or cytotoxic agents within 1 year prior to screening; 6) Individuals who received scalp radiation, and/or underwent low-energy laser therapy or scalp surgical treatment for androgenetic alopecia within 1 year prior to screening; 7) Individuals who plan to use any adjuvant therapies or concomitant treatments for hair loss during the study period; 8) Individuals with drug allergies, or known allergies to the components of the study product; 9) Individuals with a history of malignant tumors, diabetes mellitus, angina pectoris, tachycardia, or orthostatic hypotension; 10) Individuals with abnormal liver/kidney function or other clinical laboratory test results outside the normal range, which were deemed clinically significant by the investigator during screening; 11) Individuals who have undergone hair transplantation, hair weaving, or wear non-breathable wigs/hair bonding products; 12) Individuals deemed by the investigator to have other conditions that may affect compliance or make them unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Area Hair Counts; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Area Hair Width;Male Hair Growth Questionnaire;Hair Growth Assessment;Syndrome Score of Traditional Chinese Medicine;Sex Hormone Level;Parameters related to blood metabolomics;parameters related to blood lipidomics;parameters related to metabolomics of scalp surface secretions;parameters related to microbiomics of scalp surface; | — |
Countries
China
Contacts
Public ContactPing Song
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed