CTRI/2020/03/023861尚未招募2 期
Efficacy of Majoon-e-Shahtara and Zimad in Tinea cruris – An Open Labelled Single Arm Interventional Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in subjective parameters
研究概览
简要总结
| Diagnosed cases of Tinea cruris fulfilling the inclusion criteria will be enrolled into clinical trial after obtaining written informed consent. All subjects will be given test drugs Majoon-e-Shahtara 7g orally twice daily with water (after meal) and Zimad for local application twice daily for 4 weeks, followed by two weeks (35th and 42nd day) of post-trial follow ups for assessment of any relapse. Assessment of study outcome will be made on the basis of observation of baseline and each follow up in the form subjective and objective parameters. The subjective parameters will be assessed with an arbitrary grading 4 – point Likert scale (where 0 = nil, 1 = mild, 2 = moderate and 3 = severe) accordingly objective parameters like photography of the lesions and KOH microscopy will be assessed on 0th (baseline) and on 4th week. Following two more follow ups will be made to assess any relapse of the trial effect. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically and microscopically diagnosed patient of Tinea cruris Patient of either gender Age group 20-50 years Patient who have agreed to sign the informed consent form.
排除标准
- •Patient below 20 years and above 50 years of age Pregnant and lactating women Patient with severe systemic and metabolic disorders Diabetic, HIV/AIDS or other immunocompromised patients Patient with concomitant skin disease like eczema and psoriasis Patient who are taking conventional medicine for Tinea cruris will be enrolled for the trial after a washed out period of 15 days.
结局指标
主要结局
Improvement in subjective parameters
时间窗: 28 days
次要结局
- Improvement in objective parameters(28 days)
研究者
研究点 (1)
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