Evaluation dermal safeness and therapeutic effects of a herbal Body Lotio
- Registration Number
- CTRI/2020/10/028514
- Lead Sponsor
- SANGHVI BEAUTY AND TECHNOLOGIES PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects age group 18 - 55 years
2. Healthy male and female subjects
3. Subjects willing to give a written informed consent.
4. Subject has not participated in a similar investigation in the past two weeks.
5. Subjects willing to come for regular follow up.
6. Subjects ready to follow instructions during the study period.
1. Skin allergy antecedents or atopic subjects
2. Known medical history of hyper sensitivity to any herbal cosmetic products
3. Severe cutaneous disease, any chronic illness and subjects on oral corticosteroid.
4. Subjects participating in any other cosmetic or therapeutic trial.
5. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
6. Pregnant and breast feeding mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Evaluation of nourishing, moisturizing and smoothing effects as per clinical scoring systems of EEMCO for overall dry skin score (ODS) and Specified symptom sum score (SRRC) for scales, roughness, redness, and cracks. <br/ ><br>2. The subject will also be evaluation in terms of lakshanas (symptoms) defined according to Ayurvedic principles like twakasnehana, kandu etc. as per predefined visual analogue scale (VAS). Â Timepoint: Screening, 7th day and 14th dayÂ
- Secondary Outcome Measures
Name Time Method Assessment of incidence of adverse events and patient compliance to the therapy like Irritation, Erythema, Edema, Pruritus and Urticaria etc.Timepoint: Screening, 7th day and 14th day