Evaluation of Efficacy and Safety of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil in Healthy participants - An open label, non-comparative, interventional, prospective, clinical study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in skin cutaneous moisturization/skin dryness
研究概览
简要总结
It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil in Healthy participants. Subjects will be asked to apply Namskar Ayurved’s Repair and Restore Moisturizing Body Oil all over the body after taking bath every day for a period of 30 days. The primary objective of the study will be to assess change in skin cutaneous moisturization/skin dryness. The secondary objectives of the study will be to assess changes in overall skin texture/roughness (Tactile) and (Visual), changes in overall skin desquamation/flakiness and luminosity/radiance, change in facial skin lightening and blemishes on skin, assessment of 24 hr skin patch test, difference in number of comedones (blackheads and whiteheads) on the face and body, ability of study drug to absorb into the skin, oily/greasy appearance and feeling of oil on skin, global assessment for overall change by participants and by physician, assessment of post treatment tolerability of study drug by participants and physician and assessment of adverse events on 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)
Results and Conclusion:
Namskar Ayurved’s Repair and RestoreMoisturizing Body Oil was significantly effective in improving skin cutaneousmoisturization/skin dryness, skin texture/roughness (Tactile and visual), skin desquamation/flakiness, overallskin luminosity/radiance and reducing skin blemishes and comedones. It wasalso effective in improving skin colour and skin glow. It was tolerated wellby all the subjects. Hence, Namskar Ayurved’s Repair and RestoreMoisturizing Body Oil can be used daily as an effective remedy for management of skindryness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically diagnosed mild to moderate skin dryness assessed using clinical grading score 2.Willing to comply with all requirements of the study.
排除标准
- •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.
结局指标
主要结局
Change in skin cutaneous moisturization/skin dryness
时间窗: 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)
次要结局
- 1.Changes in overall skin texture/roughness (Tactile) and (Visual)(2.Changes in overall skin desquamation/flakiness and luminosity/radiance)