Clinical trial NCT06998680: 6-Month Trial of Chinese Herbal Treatments for Hair Loss and Gray Hair
Official title: A 6-Month Randomized Double-Blind Placebo-Controlled Trial Assessing the Efficacy of Oral and Topical Traditional Chinese Medicine Products on Alopecia and Canities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alopecia
Canities
Lead sponsor: Vita Green Pharmaceutical (H.K.) Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-31
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a 6-month randomized, double-blind, placebo-controlled trial. A total of 152 participants with hair loss, including some with gray hair, will be enrolled and randomly assigned to four groups. Each group will receive a combination of oral capsules and hair tonic, to be used as directed for 24 weeks. Participants will attend three in-person visits, during which assessments-including hair-related tests and photographs-will be conducted to evaluate hair count and density. Additionally, 10 participants with gray hair from each group will undergo extra assessments focused on changes in hair color. All relevant clinical data will be systematically collected and recorded for statistical analysis.


Eligibility criteria: Inclusion Criteria:

1. Participants must sign the informed consent form prior to enrollment and fully understand the study's purpose, procedures, and potential adverse events.
2. Adults aged 18 to 60 years, both male and female; each group must include no less than 50% female participants.
3. Hair length must be greater than 5 cm.
4. Women must meet the Savin scale classification between grades 1-3 to II.
5. Men must meet the Norwood-Hamilton classification between stages II and VI.
6. At least 10 participants in each group must have gray hair, with a minimum of 5 gray hairs within a 1 cm × 4 cm area of the scalp.
7. Participants must not have undergone any special hair treatments-such as dyeing, perming, or styling-within the past two months.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or individuals planning to conceive in the near future.
2. Individuals with medical conditions causing hair loss, such as refractory alopecia areata, inflammatory scarring alopecia, or psoriatic alopecia; or those diagnosed with other scalp or hair disorders.
3. Individuals with diagnosed psychiatric or psychological disorders, or those with long-term sleep disturbances or emotional regulation issues.
4. Use of anti-hair loss cosmetics or other hair growth-promoting products within the past 3 months.
5. Use of any systemic or topical medications known to affect hair growth within the past 6 months.
6. History of hair transplantation.
7. Curly hair.
8. Individuals with highly sensitive constitutions.
9. Individuals diagnosed with severe anemia or abnormal liver/kidney function during physical examination.
10. Participation in any other clinical trials involving the test area within the past 2 months.
11. Any other conditions deemed unsuitable for participation by the clinical investigators.

Primary outcomes:
measure: Hair Shedding Count
timeFrame: Baseline, week 12, week 24
measure: Local Hair Count
timeFrame: Baseline, week 12, week 24
measure: Local Hair Density
timeFrame: Baseline, week 12, week 24
measure: percentage of Vellus Hair
timeFrame: Baseline, week 12, week 24
measure: Percentage of Terminal Hair
timeFrame: Baseline, week 12, week 24
measure: Scoring of Hair Changes from Images
timeFrame: Baseline, week 12, week 24
Secondary outcomes:
measure: local hair color scores and white hair Index
timeFrame: Baseline, week 12, week 24
measure: Complete Blood Count concentrations
timeFrame: Baseline, week 24
measure: Urinalysis concentrations
timeFrame: Baseline, week 24
measure: Aspartate Aminotransferase concentrations
timeFrame: Baseline, week 24
measure: Alanine Aminotransferase concentrations
timeFrame: Baseline, week 24
measure: Creatinine concentrations
timeFrame: Baseline, week 24
measure: Urea Nitrogen concentrations
timeFrame: Baseline, week 24
measure: Serum Uric Acid concentrations
timeFrame: Baseline, week 24
measure: Adverse Events
timeFrame: Baseline, week 24
Other outcomes:
Locations:
city: XiangTan
country: China
facility: The First People's Hospital of Xiangtan City
state: Hunan
Study officials:
References: