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临床试验/CTRI/2017/06/008923
CTRI/2017/06/008923招募中3 期

An open clinical trial of Siddha drug Karunchoorai chooranam (Internal medicine) and Kodiveli Thylam (External Medicine) in the treatment of kalanjagapadai (Psoriasis)

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月3日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
40
试验地点
1
主要终点
GOOD OUTCOME-Clearence of lesions and reduction of PASI score from 3,4 to 1,2

研究概览

简要总结

It is a single non-randomised , open label trial to determine the therapeutic efficacy  of KARUNCHOORAI CHOORANAM (prepared from herbal constituents) in patients with  PSORIASIS (KALANJAGAPADAI). Karunchoorai chooranam consists of  Capparis sepiaria, Plumbago indica, Enicostemma axillare, Toddalia asiatica, Piper nigrum, Gymnema sylvestre, Corallocarpus epigaeus, Acaci anilotica and Stercularia foedita*.*  All the ingredients are purified, powdered and stored in an air tight container.In this  trial 40 patients will be recruited and the trial drug will be administered 2 gram twice a day for a period of 48 days. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmaco vigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in Indian Journal of Medical Research.

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
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Erythema 2.Thickness 3.Scaling 4.Itching; with or without itching 5.Auspitz sign + 6.Candle crease sign +.

排除标准

  • 1.Psoriatic arthropaty 2.pregnancy and lactation 3.Psoriasis with evidence of any other skin disease 4.Evidence of secondary infection 5.Leprosy 6.Systemic illness.

结局指标

主要结局

GOOD OUTCOME-Clearence of lesions and reduction of PASI score from 3,4 to 1,2

时间窗: 48 days

MODERATE OUTCOME- Partial clearence of lesions and reduction of PASI score from 3,4 to 1,2

时间窗: 48 days

POOR/NIL-No clearence of lesions or no reduction of PASI Score

时间窗: 48 days

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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