Study to Evaluate the effect and Safety of Ashwagandha Serum on the hair health in healthy adult humans.
- Registration Number
- CTRI/2022/11/047539
- Lead Sponsor
- Ixoreal Biomed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
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).
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.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method