A study to observe the efficacy of hair cleanser and conditioner containing Bhringraj and Shikakai on humans
- Registration Number
- CTRI/2022/05/042534
- Lead Sponsor
- Mountain Valley Springs India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Healthy subjects (no infectious and evaluative pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)
Indian Male/Female subjects.
Between 18 to 65 years of age, with normal Hair texture.
Hair is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
Written informed consent signed by the subject or legally acceptable representative(s) in line with applicable regulation of country.
Having refused to give her assent by not signing the consent form
Taking part in another study liable to interfere with this study
Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products
Having cutaneous hypersensitivity.
Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only scalp cleaned with water is accepted)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation will include assessment of local adverse events of redness, itching, rashes and burning sensations and any other local side effect and will be categorized non serious (based on severity grades, patterns, and causality) and serious adverse events. There will be two types of assessment, subject self-assessment, and dermatological evaluation by study investigator.Timepoint: Subject assessment will be done at The subjects will be asked to fill self-evaluation questionnaire and investigator will also assessed at 30 minutes, 15 day and 30 days after application.
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI
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