Effectiveness of Ashwagandha capsule on Skin & Hair Health in Healthy adult

Phase 4

• Registration Number: CTRI/2023/06/053659
• Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy adult men and women participants >= 18 years and <=60

years of age.

2. Willingness to follow the protocol requirements as evidenced by

written informed consent.

3. Participants who were on consistent dietary, hair, and skin product

3 months prior to start of the study and are willing to follow the same

during the study.

4. 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.

5. 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.

6. Willing to come for all follow-up visits.

7. Participants who agree not to cut hair for the entire duration of the

study.

8. Participants willing to undergo Trichoscan evaluation and not to

wash their hair 48 hours before the visit.

9. Participants willing to take proper contraceptives during the study

and period.

10. Participants or LAR can and willing to give meaningful, written

informed consent prior to participation in the trial, in accordance

with regulatory requirements.

11. Participants who agree to take investigational product (i.e., Till Day

90 ± 4 ± 4).

Exclusion Criteria

1. Participants having any clinically significant medical history,

medical finding including rosacea, eczema, psoriasis, and atopic

dermatitis 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 α-reductase inhibitor, minoxidil,

steroids, or hormonal products, during the 3 months prior to study

commencement.

3. Participants having a history of hypersensitivity reactions (i.e.,

allergic or oversensitivity to study medication).

4. Participants who have undergone or plan to undergo hair

transplantation surgery during the study period.

5. Participants with facial skin cancer.

6. Participants with sunburn, moderate to pronounced suntan, uneven

skin tones, tattoos, scars or other disfiguration, dilated vessels or

other conditions on the test area that might influence the test results.

7. Participants with severe seborrheic dermatitis, alopecic disease,

except for androgenic alopecia, and scalp disorders, such as scalp

psoriasis and infection

8. Participants who have participated in a clinical study during the

preceding 180 days.

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

eating disorders, etc.).

10. Pregnant and lactating females

11. Participants with alcohol addiction or persistent abuse of drugs of dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified