None listed
Conditions
Interventions
Intervention1: KSM-66 Ashwagandha Hair serum: KSM-66 Ashwagandha Hair serum 2 drops (2ml) applying the hair serum daily once for 75 days
Control Intervention1: Placebo serum: Applying the hair serum d
Sponsors
Ixoreal Biomed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult healthy male/ female participants more than equal to 18 years and less than equal to 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. 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 are able to 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 75 ± 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 aplha-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 |
|---|---|
| Mean change in hair analysis parameter, hair density (n/cm2 ), hair diameter (µm), hair growth rate (mm/day), or anagen/telogen ratio ( Hair Analysis by Trichoscan) from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4). Mean change in the shedding range of the hair in the “60 Second Hair Comb test ? from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4).Timepoint: Baseline and Day 75 ± 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in (hair thinning and hair fall assessment) IGA scale score from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4) 2. Change in mean levels of shedding range of the hair via hair pull test from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4). 3. Mean change in QoL (hair-specific Skindex-29 scores from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4). 4. Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 11 weeks’ treatment periodTimepoint: Baseline and Day 75 ± 4 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed