Effectiveness of Ashwagandha Serum on the Hair Health in Adults
Not Applicable
Recruiting
- Conditions
- Male and Female 18 to 45 years of age
- Registration Number
- CTRI/2023/06/053920
- Lead Sponsor
- Ixoreal Biomed Private Limited
- Brief Summary
All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
Subjects will be informed about the purpose of the study and signed informed consent will be taken.
The efficacy assessments mentioned above will be done appropriately during the study.
All Subjects will be followed-up during the study period (Screening /Baseline, Day-45 (telephonic),and Day 90 ± 4) till complete the course of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Adult healthy male/ female participants ≥ 18 years and ≤45 years of age.
- Willingness to follow the protocol requirements as evidenced by written informed consent.
- 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.
- 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.
- Participants willing to come for all follow-up visits.
- Participants agreeing for not cutting hair for the entire duration of study.
- Participants willing to undergo Trichoscan preparation and not to wash their hair 48 hour before the visit.
- Participants willing to follow consistent dietary, hair product usage during the study.
- Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- Participants who agree to take investigational product (i.e., Till Day 90 ± 4).
Exclusion Criteria
- Participants having any clinically significant medical history, medical finding or an ongoing 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.
- 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.
- Participants having a history of hypersensitivity reactions.
- 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.
- Pregnant and lactating females.
- Participants with severe seborrheic dermatitis, alopecic disease (except for androgenic alopecia) and scalp disorders, such as scalp psoriasis and infection.
- Participants with any disease or condition of the skin that the investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis.
- Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 60 Second Hair Comb test Baseline, 12 weeks
- Secondary Outcome Measures
Name Time Method MSCR 10-point scale score Hair pull test score Baseline, 12 weeks Hair-specific Skindex-29 Baseline, 12 weeks
Trial Locations
- Locations (1)
MGM Medical College & Hospital
🇮🇳Raigarh, MAHARASHTRA, India
MGM Medical College & Hospital🇮🇳Raigarh, MAHARASHTRA, IndiaMeghana PhiskePrincipal investigator9819030429phiskemeghana@gmail.com