A 6-Month Randomized Double-Blind Placebo-Controlled Trial Assessing the Efficacy of Oral and Topical Traditional Chinese Medicine Products on Alopecia and Canities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- percentage of Vellus Hair
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must sign the informed consent form prior to enrollment and fully understand the study's purpose, procedures, and potential adverse events.
- •Adults aged 18 to 60 years, both male and female; each group must include no less than 50% female participants.
- •Hair length must be greater than 5 cm.
- •Women must meet the Savin scale classification between grades 1-3 to II.
- •Men must meet the Norwood-Hamilton classification between stages II and VI.
- •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.
- •Participants must not have undergone any special hair treatments-such as dyeing, perming, or styling-within the past two months.
Exclusion Criteria
- •Pregnant or breastfeeding women, or individuals planning to conceive in the near future.
- •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.
- •Individuals with diagnosed psychiatric or psychological disorders, or those with long-term sleep disturbances or emotional regulation issues.
- •Use of anti-hair loss cosmetics or other hair growth-promoting products within the past 3 months.
- •Use of any systemic or topical medications known to affect hair growth within the past 6 months.
- •History of hair transplantation.
- •Curly hair.
- •Individuals with highly sensitive constitutions.
- •Individuals diagnosed with severe anemia or abnormal liver/kidney function during physical examination.
- •Participation in any other clinical trials involving the test area within the past 2 months.
- •Any other conditions deemed unsuitable for participation by the clinical investigators.
Arms & Interventions
Capsule Placebo+VitaGreen Tonic
Intervention: Capsule Placebo+VitaGreen Tonic (Other)
Capsule Placebo+Tonic Placebo
Intervention: Capsule Placebo+Tonic Placebo (Other)
VitaGreen Capsule A+VitaGreen Tonic
Intervention: VitaGreen Capsule A+VitaGreen Tonic (Other)
VitaGreen Capsule B+VitaGreen Tonic
Intervention: VitaGreen Capsule B+VitaGreen Tonic (Other)
Outcomes
Primary Outcomes
percentage of Vellus Hair
Time Frame: Baseline, week 12, week 24
Detected by Dermatoscope
Hair Shedding Count
Time Frame: Baseline, week 12, week 24
Combing the hair 60 times and recording the number of hairs that fall out during the process
Local Hair Count
Time Frame: Baseline, week 12, week 24
Detected by Dermatoscope
Local Hair Density
Time Frame: Baseline, week 12, week 24
Detected by Dermatoscope
Percentage of Terminal Hair
Time Frame: Baseline, week 12, week 24
Detected by Dermatoscope
Scoring of Hair Changes from Images
Time Frame: Baseline, week 12, week 24
Doctor scores hair changes from Images pictured by camera with scale of 0 to 4
Secondary Outcomes
- local hair color scores and white hair Index(Baseline, week 12, week 24)
- Complete Blood Count concentrations(Baseline, week 24)
- Urinalysis concentrations(Baseline, week 24)
- Aspartate Aminotransferase concentrations(Baseline, week 24)
- Alanine Aminotransferase concentrations(Baseline, week 24)
- Creatinine concentrations(Baseline, week 24)
- Urea Nitrogen concentrations(Baseline, week 24)
- Serum Uric Acid concentrations(Baseline, week 24)
- Adverse Events(Baseline, week 24)