Actively Recruiting
A 6-Month Randomized Double-Blind Placebo-Controlled Trial Assessing the Efficacy of Oral and Topical Traditional Chinese Medicine Products on Alopecia and Canities
Led by Vita Green Pharmaceutical (H.K.) Ltd. · Updated on 2025-09-19
152
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of traditional Chinese herbal products on hair loss (alopecia) and gray hair (canities) in adults aged 18 to 60 years. This 6-month randomized, double-blind, placebo-controlled trial will enroll 152 participants, including some with gray hair, to study changes in hair count, density, and color. The trial aims to better understand how oral capsules and topical hair tonics may impact hair health. Participants will be randomly assigned to one of four groups, each receiving a combination of oral capsules and hair tonic or placebos for 24 weeks. The groups include VitaGreen Capsule A plus VitaGreen Tonic, VitaGreen Capsule B plus VitaGreen Tonic, Capsule Placebo plus VitaGreen Tonic, and Capsule Placebo plus Tonic Placebo. Treatments will be used as directed throughout the 24-week period. During the study, participants will attend three in-person visits at baseline, week 12, and week 24. Hair-related assessments include hair shedding counts, local hair counts, hair density, and photographic scoring of hair changes. A subset of participants with gray hair will have additional evaluations of hair color changes. Blood tests, urinalysis, and safety monitoring for adverse events will also be conducted. All clinical data will be collected for analysis, with the total participation lasting about six months.
CONDITIONS
Brief Title
6-Month Trial of Chinese Herbal Treatments for Hair Loss and Gray Hair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign the informed consent form and understand the study's purpose, procedures, and potential adverse events.
- Adults aged 18 to 60 years, both male and female; each group must have at least 50% female participants.
- Hair length must be greater than 5 cm.
- Women must have hair loss classified as Savin scale grades 1-3 to II.
- Men must have hair loss classified as Norwood-Hamilton stages II to VI.
- At least 10 participants in each group must have gray hair with a minimum of 5 gray hairs in a 1 cm × 4 cm scalp area.
- No special hair treatments such as dyeing, perming, or styling within the past two months.
You will not qualify if you...
- Pregnant or breastfeeding women, or those planning to conceive soon.
- Medical conditions causing hair loss like refractory alopecia areata, inflammatory scarring alopecia, psoriatic alopecia, or other scalp/hair disorders.
- Diagnosed psychiatric or psychological disorders, long-term sleep disturbances, or emotional regulation issues.
- Use of anti-hair loss cosmetics or hair growth products within the past 3 months.
- Use of systemic or topical medications affecting hair growth within the past 6 months.
- History of hair transplantation.
- Curly hair.
- Highly sensitive constitution.
- Severe anemia or abnormal liver/kidney function found during physical exam.
- Participation in other clinical trials involving the test area within the past 2 months.
- Any other conditions deemed unsuitable by clinical investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive oral and topical traditional Chinese medicine products for hair loss and gray hair.
Visits at Baseline, Week 12, and Week 24
Trial Site Locations
Total: 1 location
1
The First People's Hospital of Xiangtan City
Xiangtan, Hunan, China, 411100
Actively Recruiting
Research Team
N
Naya Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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