None listed
Conditions
Interventions
Intervention1: KSM-66 capsules containing
Ashwagandha 300 mg standardized root extract: Standardized root extract 300
mg to be taken two times in a
day orally with water/milk for
period of 12 weeks
Co
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
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
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 a-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trans Epidermal Water Loss (TEWL) AssessmentTimepoint: Baseline, 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression – Improvement scale (CGI-I)Timepoint: Baseline, 12 Weeks;DLQI Questionnaire score assessmentTimepoint: Baseline, 12 Weeks;Hair Skindex-29 Questionnaire score assessmentTimepoint: Baseline, 12 Weeks;Subjects Self-Assessment of improvementTimepoint: Baseline, 12 Weeks;Trichoscan analysisTimepoint: Baseline, 12 Weeks | — |
Countries
India
Contacts
Public ContactDeepakkumar Langade
D Y Patil Medical College Hospital and Research Centre
Outcome results
None listed