CTRI/2022/02/040587尚未招募3 期
RANDOMISED CONTROLLED CLINICAL STUDY OF AROGYAMISHRAN ANDTANKANAMISHRAN IN DADRU W.S.R. TO TINEA
Dr Suryakiran Parashuram Wagh2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cure of Dadru kushta signs and symptoms Kandu (Pruritus)
研究概览
简要总结
Background of study is that Dadru wsr Tinea infections recurrence is high, there is need of long standing solution to avoid the recurrence of the disease. This is randomised controlled open clinical trial. both arms with 60 patients intervention for 15 days. Expected primary outcome is patients will became sign and symptom free and secondary outcome will that there should not be recurrence for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 14.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having the clinical features of dadru.
- •Patients ready to abide trial procedure to give informed consent.
排除标准
- •Patients aged below 14 & above 60 years.
- •Pregnant women & lactating mothers.
- •Patient of other skin disease like psoriasis, seborrhic dermatitis, lichen simplex, chronicus, pityriasis versicolor, eczema, candidiasis.
- •Patients having any known severe systemic diseases of renal, hepatic cardiac disorders, diabeties mellitus, tuberculosis, immuno deficiency syndrome, leprosy, malignant disease.
- •5.Patients having known drug allergy of sulphur, mercury.
结局指标
主要结局
Cure of Dadru kushta signs and symptoms Kandu (Pruritus)
时间窗: 2 months
Raga (Erythema)
时间窗: 2 months
Number of Mandala
时间窗: 2 months
Size of Mandala
时间窗: 2 months
次要结局
- no recurrence of Dadru(4 weeks)
研究者
研究点 (2)
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