Study to check the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Skin and Hair Health in Healthy Men and Wome

Not Applicable

Completed

• Registration Number: CTRI/2022/11/047577
• Lead Sponsor: Ixoreal Biomed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

1.Healthy adult men and women participants more than equal to 18 years and less than equal to 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.

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 are able to 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 75 ± 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 alpha-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

Primary Outcome Measures

Name	Time	Method
Mean change in TEWL from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Week 11)Timepoint: Baseline and Week 11

Secondary Outcome Measures

Name	Time	Method
1. Mean change in hair density (n/cm2 ), hair diameter (µm), hair growth rate (mm/day), and Anagen/Telogen ratio (hair analysis by Trichoscan) from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Week 11) <br/ ><br>2. Mean change in DLQI Questionnaire score from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Week 11) <br/ ><br>3. Mean change in Hair Skindex-29 Questionnaire score from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Week 11) <br/ ><br>4. Self-Assessment of improvement (hair and skin health) on 1-7 Likert scale scores at Visit 3, End of study (Week 11) <br/ ><br>5. Global Physician Assessment score (1-7 Likert scale) at Visit 3, End of study (Week 11) <br/ ><br>6. Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE)Timepoint: Baseline and Week 11