A STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF A HERB IN ADULT MALE SUBJECTS EXHIBITING MALE PATTERN BALDNESS
- Registration Number
- CTRI/2011/12/002198
- Lead Sponsor
- Gencor Pacific Organics India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1.Male subjects between ages of 18 to 41 years (both years inclusive).
2.Subjects must be able to be classified under any of the scales of Norwood / Hamilton Scale for menâ??s hair loss.
3.Subjects who are not using any other hair growth products for the last 30 days.
4.Subjects should agree to not use any other hair growth products during the study.
5.Subjects should agree to not to alter their hair style or dye their hair during the study.
6.Subjects should be able to comply with the study procedures and Schedule.
7.Subjects should be able to understand study information provided and give informed consent, after being explained by the study team.
1.Subjects suffering from mycotic infections.
2.Subjects who have taken radiotherapy to scalp for cancer treatment.
3.Subjects with a history of systemic malignancy.
4.Subjects with a history of cutaneous malignancy.
5.Subjects with Nevi / cutaneous lesion currently.
6.Subjects with an evidence of an immune-compromised state.
7.Subjects with poorly controlled diabetes.
8.Subjects with clinically significant medical complaints.
9.Subjects with known psychiatric disease.
10.Subjects with serious local infection (e.g. cellulites, abscess) within 90 days of the signing of the informed consent
11.Subjects with systemic infection (e.g., pneumonia, septicemia) within 90 days of the signing of the informed consent.
12.Subjects with known hypothyroidism.
13.Subjects with known hyperthyroidism.
14.Subjects with Cicatricial alopecia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objectives of this study are to evaluate the clinical efficacy and safety of Ageratum conyzoidesâ??s Oil Formulation in adult Indian Males Subjects exhibiting Androgenic Alopecia (Male Pattern Baldness).Timepoint: 90 DAYS
- Secondary Outcome Measures
Name Time Method Safety parametersTimepoint: 90 days treatment period