Clinical study on Namskar Ayurved’s Repair and Restore Moisturizing Body Oil
- Registration Number
- CTRI/2022/07/044468
- Lead Sponsor
- amaskar Ayurved Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
1.Clinically diagnosed mild to moderate skin dryness assessed using clinical grading score
2.Willing to comply with all requirements of the study.
1.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
2.Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
3.Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
4.Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs. Moisturizing cream, lotion or oil within 21 days before entering the trial
5.Subjects on any other investigational products within 1 month prior to randomization
6.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
7.Pregnant and lactating women
8.Known hypersensitivity to any of the ingredients of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil
9.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in skin cutaneous moisturization/skin drynessTimepoint: Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)
- Secondary Outcome Measures
Name Time Method 1.Changes in overall skin texture/roughness (Tactile) and (Visual) <br/ ><br>2.Changes in overall skin desquamation/flakiness and luminosity/radiance <br/ ><br>3.Change in facial skin lightening and blemishes on skin <br/ ><br>4.Assessment of 24 hr skin patch test <br/ ><br>5.Difference in number of comedones (blackheads and whiteheads) on the face and body <br/ ><br>6.Assessment of ability of study drug to absorb into the skin, oily/greasy appearance and feeling of oil on skin <br/ ><br>7.Global assessment for overall change by participants and by physician <br/ ><br>8.Assessment of post treatment tolerability of study drug by participants and physician. <br/ ><br>9.Assessment of adverse events <br/ ><br>Timepoint: Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)