A Prospective, Randomized, Self-Controlled 21 day Clinical Study to evaluate the effect of topical application of Snigdhkanti Ayurvedic Skin Healing Cream.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the effect of topical application of Snigdhkanti Ayurvedic formulation as a skin healing cream.
研究概览
简要总结
A 21 day self-controlled study on the effect of topical application of Snighdkanti- a 100% natural ayurvedic cream is to be conducted. A total number of 30 subjects are to be recruited as per the inclusion criteria. Thecream is to be liberally applied on the target area as per area of topicalapplication. The quantity of Snigdhkanti Neem Sandal Cream is to be determinedby the physician At the end of the trial the data gathered on Day 0, Day 10 and Day 21 will be assessed, analyzed and the results and discussions will be recorded. This study will beconducted in compliance with the protocol approved by the IEC. No deviationfrom the protocol will be implemented without the prior review and approval ofthe IEC except where it may be necessary to eliminate an immediate hazard to aresearch subject. In such case, the deviation will be reported to the IEC assoon as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Any male or female adults between 18-65 years 2.Subject who is willing to give consent and is able to comply with all trial requirements.
- •3.Subjects with all skin types 4.Subjects who have cracked lips, cracks on skin, excessive dry skin, skin rash, itchiness of skin and other related fungal conditions 5.Subjects who have under-eye darkness 6.Being mentally competent and able to understand all study requirements and sign the informed consent form.
排除标准
- •1.Subjects with chronic diseases like severe liver, renal, cardiac or brain diseases.
- •2.Pregnant or lactating women 3.Allergic to any medication 4.With a history of alcohol and/or drug abuse.
结局指标
主要结局
To assess the effect of topical application of Snigdhkanti Ayurvedic formulation as a skin healing cream.
时间窗: Day 0, Day 10, Day 21
次要结局
- To assess its efficacy in nourishing and softening the skin.(Day 0, Day 10, Day 21)