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

Not Applicable

Completed

• Conditions: Beneficial for hair, Hair fall, Greying of hair and Dandruff

• Registration Number: CTRI/2023/06/054189
• Lead Sponsor: Aryanveda Cosmeceuticals

Brief Summary

This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson Amla oil with Vitamin C in benefitting the hair growth, reducing hairfall, greying of hair and dandruff.

Primary Objective

• Reduction in the shedding range of the hair in the “60 sec Hair comb test†from Visit 1 to the end of the study.

• Reduction in the “Adherent Scalp Flaking Score†from Visit 1 to the end of the study.



Secondary Objective

• Reasonable improvement in the “Subjective Hair Assessment Questionnaire†score from Visit 1 to the end of the study.

• Reasonable improvement the “Subject IP Feedback Questionnaire†score from Visit 2 to end of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-07
• Study Completion: 2023-07-27
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• Subjects on topical treatment for alopecia, premature graying of the hair and seborrheic dermatitis for 8 weeks prior to enrollment.
• Subject with other dermatological disorders of the scalp that might interfere with the study evaluation.
• Subjects with significant scalp scarring.
• Subjects who have anemia or iron deficiency.
• Subjects who have previously undergone hair transplantation procedures.
• History of systemic or cutaneous malignancy or evidence of immunocompromised state.
• Subjects with history of skin allergy.
• Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
• Female subjects who are reported pregnant/planning a pregnancy or lactating.
• Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
• 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 testâ€	Day 42
from visit 1 to the end of the study.	Day 42
• Excellent reduction in the flaking severity in the “Adherent Scalp Flaking Score†from visit 1 to the end of the study.	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.	• Reasonable improvement the “Subject IP Feedback Questionnaire†score from Visit 2 to end of study.

Trial Locations

Locations (1)

Dr. Uday’s Advance Skin and Hair clinic; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Uday’s Advance Skin and Hair clinic

🇮🇳Bangalore, KARNATAKA, India

Dr Uday Kumar

Principal investigator

6364147980

info@samahitha.com