CTRI/2023/02/049832招募中2/3 期
A Single Arm Clinical Study to evaluate the efficacy of Gojivhadi Malahara in Ahiputana (Napkin Dermatitis) in infants.
Dr Umang Varshney1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年1月3日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To decrease kandu(itching) and pidika over perianal region.
研究概览
简要总结
This is a single Arm clinical study in which Gojivhadi Malahara will be provided to 38 patients showing signs and symptoms of Ahiputana (Napkin Dermatitis). The age group taken for the study trial will be infants up to 1 year. The mode of drug administration will be by external application in form of malahara. Patients will be examined on first day and follow up on 3rd & 7th day will be taken. Total duration of drug administration for trial will be of 7 days.
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
- 0.00 Day(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Infants who suffer with Ahiputana.
- •Infants age up to 1 year.
- •Patients will be selected irrespective of sex and socioeconomic status.
- •The Patients whose parents are ready to participate in the clinical trial by giving informed written consent.
排除标准
- •Infants having other generalized skin infections.
- •Infants having life threatening illness.
- •Infants who are known case of systemic illness.
- •Infants who have other than clinical signs and symptoms of Ahiputana.
- •Children above 1 year of age.
- •History of Ahiputana more than 10 days.
结局指标
主要结局
To decrease kandu(itching) and pidika over perianal region.
时间窗: 7 days study with follow up on 3rd and 7th day(0,3,7)
次要结局
- To Observe the adverse effects , if any(7 days study with follow up on 3rd and 7th day(0,3,7))
研究者
研究点 (1)
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