Efficacy and safety evaluation study of Herb-o-ville Sneha Massage Oil for use as a rejuvenating massage tailum in healthy human adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To examine the effect of the test substance on the efficacy and tolerability on skin, To examine the effect of the test substance on the efficacy and tolerability on skin
研究概览
简要总结
Herb-o-ville body massage Oil is a poly herbal formulation composed of 14 roots, fruits, stem, leaves and seeds described in the First Schedule of the AYUSH ministry infused in a medium of sesame oil and milk.
Pre-Clinical Tests performed at a Dept. of Ayush, Govt. Approved Laboratory testing facility and our GMP certified Ayurvedic Drug Manufacturing unit for the following analytical parameters
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Descriptive studies: Color, Odor, Touch
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Weight per ml
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Microbiological Contamination: Total Bacterial count, Total Fungal count. 4) Heavy metal test
2 Trial Objectives
To evaluate the efficacy and safety of a rejuvenating Ayurvedic facial massage using an oil serum in healthy human adults.
To study the irritation potential of a rejuvenating Ayurvedic facial massage using an oil serum in healthy human volunteers using dermatological evaluation by single occlusive patch test method.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy individuals between the age group of 15-55 years old, whose skin types are representative of type III, IV, V, VI skin types as per the Fitzpatrik scale.
- •Being mentally competent and able to understand all study requirements and sign the informed consent form.
排除标准
- •Subjects with severe liver, renal, cardiac or brain diseases.
- •Pregnant or lactating women or women of childbearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
- •Unable to complete follow up.
- •Allergic to any medication.
- •With a history of alcohol and/or drug abuse.
结局指标
主要结局
To examine the effect of the test substance on the efficacy and tolerability on skin, To examine the effect of the test substance on the efficacy and tolerability on skin
时间窗: Day 0, Day 7 and Day 14
次要结局
- Secondary outcome measures(To examine the influence of test substance on muscle stiffness, skin smoothness and joint movements)