Clinical trial of hair vitamin gummies to improve hair and nail health
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2023/03/050199
- Lead Sponsor
- Mosaic Wellness Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and female subjects in general good health;
2.Subjects in the age group of 18-35 years (both inclusive);
3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit;
4. Female subjects falling under Grade roman number one-1 to roman number two-1 of Savins pictorial grading of female pattern hair loss or male subjects falling under Grade two to four A of hair loss severity grade evaluated as per Norwood scale;
5.Subject with at least one of the following complaints-
•Dry damaged hair
•Brittle and thin hair
•Hair loss evident while combing or after washing
•Perceived reduced hair density
•Scalp related complaints like itching, dandruff or irritation.
1.Subjects who are undergoing hair growth treatment within 3 months before screening into the study;
2.Subjects having any active scalp disease which may interfere in the study;
3.Subjects on treatment for active acne;
4.Subjects with history or active phase of malignancy and chemotherapy;
5.Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania;
6.Subjects who have had hair transplant;
7.Subjects who take pharmaceutical product which cause hirsutism;
8.Subjects on oral hair growth medications which will compromise the study;
9.Chronic illness which may influence the study;
10.Subjects participating in other similar cosmetic or therapeutic trial within last two weeks;
11.Pregnant or lactating mothers;
12.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension (â?º140/90 mmHg), HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness;
13.Any other condition, as per the discretion of the investigator, that can impact the study outcome or subjects will not be considered in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in the hair density in the target area by phototrichogram at screening visit and end of the study. <br/ ><br>2.Change in hair growth rate from screening visit to end of the study. <br/ ><br>3.Change in anagen to telogen ratio (A/T ratio) at screening visit and end of the study.Timepoint: Screening, day 30, day 60 and day 90
- Secondary Outcome Measures
Name Time Method 1.Change in the number of terminal hairs, vellus hairs and hair diameter in the target area by phototrichogram at screening visit and end of the study. <br/ ><br>2.Change in the number of shredded hairs after â??60 Second Hair Comb testâ?? from screening to end of the study. <br/ ><br>3.Change in the number of shredded hairs after â??Modified hair wash testâ?? from screening to end of the study. <br/ ><br>4.Change in nail growth rate assessed by dermatologist from screening visit to end of the study. <br/ ><br>5.Change in self-assessment questionnaire score for hair and nail at screening and end of the study. <br/ ><br>6.Change in visual analog scale (VAS) score for scalp related complaints like itching, dandruff or irritation reported by subjects from screening to end of the study.Timepoint: Screening, day 30, day 60 and day 90