Efficacy and Safety Evaluation study of Amritbindu siddha tailum (Ayurvedic Oil Serum) for use a rejuvenating facial massage in healthy human adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To examine the effect of the test substance on the efficacy and tolerability of facial skin
研究概览
简要总结
In an open label study, the efficacy and safety of Amritbindu siddha tailam as a rejuvenating facial massage will be investigating in healthy human voluteers. Twenty six participants whose skin types are representative of all VI skin types as per the Fitzpatrik scale will be receiving the treatment for 8 days (applying oil on face once daily). The efficacy of Amritbindu facial therapy will be assessing using efficacy and tolerability assessment tool on day 04 and 08. The influence of Amritbindu ayurvediya face serum on sleeping pattern will be assessing on day 04 and day 08. Subjects will be specifically asked about presence or absence of any side effects during the treatment.
Amritbindu Siddha Tailam, a poly-herbal tailam containing the following ingredients: Vetiveria zizanioides (Vetiver), Aloevera, Ocimum tenuiflorum (Thulasi), Emblica officinalis (Amla), Psoralea corylifolia (Babchi), Asparagus racemosus (Shatavari), Glycyrrhiza glabra (Licorice), Rubia cordifolia (Manjishta), Curcuma amada (mango ginger) and base oil (coconut oil, sesame oil and clarified butter).
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
- 15.00 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 all 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 of facial skin
时间窗: On day 04 and 08
次要结局
- To examine the influence of Amritbindu Ayurvediya Face Serum on sleeping pattern of the subject.(On day 04 and 08)