Alopecia, Canities
Conditions
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.
Interventions
OTHERVitaGreen Capsule A+VitaGreen Tonic
VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks
OTHERVitaGreen Capsule B+VitaGreen Tonic
VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks
OTHERCapsule Placebo+VitaGreen Tonic
Capsule Placebo+VitaGreen Tonic,use 24 weeks
OTHERCapsule Placebo+Tonic Placebo
Capsule Placebo+Tonic Placebo,use 24 weeks
Sponsors
Vita Green Pharmaceutical (H.K.) Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Shedding Count | 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 | Baseline, week 12, week 24 | Detected by Dermatoscope |
| Local Hair Density | Baseline, week 12, week 24 | Detected by Dermatoscope |
| percentage of Vellus Hair | Baseline, week 12, week 24 | Detected by Dermatoscope |
| Percentage of Terminal Hair | Baseline, week 12, week 24 | Detected by Dermatoscope |
| Scoring of Hair Changes from Images | Baseline, week 12, week 24 | Doctor scores hair changes from Images pictured by camera with scale of 0 to 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urea Nitrogen concentrations | Baseline, week 24 | Blood sample detected by Biochemical Analyzer |
| local hair color scores and white hair Index | Baseline, week 12, week 24 | Doctor evaluates local hair color scles according to Wig Color Grading（Value1 to Value 6）and calculates the white hair Index |
| Adverse Events | Baseline, week 24 | counting and documenting adverse events happening during the experiment |
| Serum Uric Acid concentrations | Baseline, week 24 | Blood sample detected by Biochemical Analyzer |
| Complete Blood Count concentrations | Baseline, week 24 | Blood sample detected by Hematology Analyzer |
| Urinalysis concentrations | Baseline, week 24 | Urine sample detected by Urine Analyzer |
| Aspartate Aminotransferase concentrations | Baseline, week 24 | Blood sample detected by Biochemical analyzer |
| Alanine Aminotransferase concentrations | Baseline, week 24 | Blood sample detected by Biochemical analyzer |
| Creatinine concentrations | Baseline, week 24 | Blood sample detected by Biochemical Analyzer |
Countries
China
Contacts
Primary ContactNaya Chen
Outcome results
None listed