A clinical study to evaluate the safety and efficacy of Nimson Amla Oil with Vitamin C in benefitting the hair growth ,reducing hair fall, greying of hair and dandruff
- Registration Number
- CTRI/2023/06/054189
- Lead Sponsor
- Aryanveda Cosmeceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subjects aged between 18 to 65 years.
2. Subjects who willing to give written informed consent and ready to comply with the protocol.
3. Subjects with active alopecia, premature greying of hair - seborrheic dermatitis of the scalp – Total ASFS Score = 16
4. Subjects with a minimum hair length of 2 inches and willing to maintain the same minimum length,
hair style until the end of the study.
1. Subjects on topical treatment for alopecia, premature graying of the hair and seborrheic
dermatitis for 8 weeks prior to enrollment.
2. Subject with other dermatological disorders of the scalp that might interfere with the study
evaluation.
3. Subjects with significant scalp scarring.
4. Subjects who have anemia or iron deficiency.
5. Subjects who have previously undergone hair transplantation procedures.
6. History of systemic or cutaneous malignancy or evidence of immunocompromised state.
7. Subjects with history of skin allergy.
8. Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
9. Female subjects who are reported pregnant/planning a pregnancy or lactating.
10. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
11. Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Excellent reduction in the shedding range of the hair in the 60 Second Hair Comb test ? <br/ ><br>from visit 1 to the end of the study. <br/ ><br>• Excellent reduction in the flaking severity in the Adherent Scalp Flaking Score ? from visit 1 to the end of the study.Timepoint: Day 42
- Secondary Outcome Measures
Name Time Method • Reasonable improvement in the Subjective Hair Assessment Questionnaire ? score from visit 1 to end of the study. <br/ ><br>• Reasonable improvement the Subject IP Feedback Questionnaire ? score from Visit 2 to end of study.Timepoint: Day 42