Effectiveness of Ashwagandha Serum on the Hair Health in Adults

Phase 4

Registration Number: CTRI/2023/06/053920

Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Adult healthy male/ female participants = 18 years and =45 years of age.

2. Willingness to follow the protocol requirements as evidenced by written informed

consent.

3. Participants who agree not to use any medication (prescription and over the counter),

including vitamins and minerals, during or before the course of this study.

4. Participants with mild to moderate hair loss classified as the Norwood-Hamilton type II, III, IV and V in males and Ludwig type I and II in females.

5. Participants willing to come for all follow-up visits.

6. Participants agreeing for not cutting hair for the entire duration of study.

7. Participants willing to undergo Trichoscan preparation and not to wash their hair 48

hour before the visit.

8. Participants willing to follow consistent dietary, hair product usage during the study.

9. Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.

10. Participants who agree to take investigational product (i.e., Till Day 90 ± 4)

Exclusion Criteria

1. Participants having any clinically significant medical history, medical finding or an on going medical or psychiatric condition exists which in the opinion of the Investigator

could jeopardize the safety of the subject, impact validity of the study results or interfere

with the completion of study according to the protocol.

2. Participants on any medication or supplement for hair loss, including finasteride, any

other 5 a-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3

months prior to study commencement.

3. Participants having a history of hypersensitivity reactions.

4. Participation in a clinical study during the preceding 180 days

5. Participants who have undergone or plan to undergo hair transplantation surgery during

the study period.

6. Pregnant and lactating females.

7. Participants with severe seborrheic dermatitis, alopecic disease (except for androgenic

alopecia) and scalp disorders, such as scalp psoriasis and infection.

8. Participants with any disease or condition of the skin that the investigator deems

inappropriate for participation, including rosacea, eczema, psoriasis, and atopic

dermatitis.

9. Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
60 Second Hair Comb testTimepoint: Baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Hair pull test scoreTimepoint: Baseline, 12 weeks;Hair-specific Skindex-29Timepoint: Baseline, 12 weeks;MSCR 10-point scale score <br/ ><br>Timepoint: Baseline, 12 weeks