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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VitaGreen Capsule A+VitaGreen Tonic | Experimental |
| |
| VitaGreen Capsule B+VitaGreen Tonic | Experimental |
| |
| Capsule Placebo+VitaGreen Tonic | Experimental |
| |
| Capsule Placebo+Tonic Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitaGreen Capsule A+VitaGreen Tonic | Other | VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hair Shedding Count | Combing the hair 60 times and recording the number of hairs that fall out during the process | Baseline, week 12, week 24 |
| Local Hair Count | Detected by Dermatoscope | Baseline, week 12, week 24 |
| Local Hair Density | Detected by Dermatoscope | Baseline, week 12, week 24 |
| percentage of Vellus Hair | Detected by Dermatoscope | Baseline, week 12, week 24 |
| Percentage of Terminal Hair | Detected by Dermatoscope | Baseline, week 12, week 24 |
| Scoring of Hair Changes from Images | Doctor scores hair changes from Images pictured by camera with scale of 0 to 4 | Baseline, week 12, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| local hair color scores and white hair Index | Doctor evaluates local hair color scles according to Wig Color Grading(Value1 to Value 6)and calculates the white hair Index | Baseline, week 12, week 24 |
| Complete Blood Count concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naya Chen | Contact | 86-021-31073699 | chenyinghuixuan@cti-cert.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Xiangtan City | Recruiting | Xiangtan | Hunan | 411100 | China |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| VitaGreen Capsule B+VitaGreen Tonic | Other | VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks |
|
| Capsule Placebo+VitaGreen Tonic | Other | Capsule Placebo+VitaGreen Tonic,use 24 weeks |
|
| Capsule Placebo+Tonic Placebo | Other | Capsule Placebo+Tonic Placebo,use 24 weeks |
|
Blood sample detected by Hematology Analyzer
| Baseline, week 24 |
| Urinalysis concentrations | Urine sample detected by Urine Analyzer | Baseline, week 24 |
| Aspartate Aminotransferase concentrations | Blood sample detected by Biochemical analyzer | Baseline, week 24 |
| Alanine Aminotransferase concentrations | Blood sample detected by Biochemical analyzer | Baseline, week 24 |
| Creatinine concentrations | Blood sample detected by Biochemical Analyzer | Baseline, week 24 |
| Urea Nitrogen concentrations | Blood sample detected by Biochemical Analyzer | Baseline, week 24 |
| Serum Uric Acid concentrations | Blood sample detected by Biochemical Analyzer | Baseline, week 24 |
| Adverse Events | counting and documenting adverse events happening during the experiment | Baseline, week 24 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |