None listed
Conditions
Interventions
Intervention1: Ashwagandha topical formulation: Ashwagandha topical serum to be applied two times daily for 90 days
Control Intervention1: Identical Placebo formulation: identical Placebo serum to be
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult healthy male/ female participants >= 18 years and 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
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 α-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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 60 Second Hair Comb testTimepoint: Baseline, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Hair pull test scoreTimepoint: Baseline, 12 weeks;Hair-specific Skindex-29Timepoint: Baseline, 12 weeks;MSCR 10-point scale scoreTimepoint: Baseline, 12 weeks | — |
Countries
India
Contacts
Public ContactDeepakkumar Langade
D Y Patil Medical College Hospital and Research Centre
Outcome results
None listed