An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "Vishnu Chakra Mathirai"(Internal)"Kodiveli Thylam "(External) for the treatment of Pakkavatham(Hemiplegia)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ability to perform day to day activities well.
研究概览
简要总结
Phase II criteria based clinical study to evaluate the clinical efficacy of siddha herbo mineral formulation on Vishnuchakra mathirai 130mg twice a day with thirikadugu choornam +inji juice &honey (Internal) for 48 days and Kodiveli thylam 30 ml (External) for 48 days in the treatment of pakkavatham(Hemiplegia) during the trail period of one year six months that will be conducted in government siddha medical college and hospital , palayamkottai , tirunelveli , tamilnadu . the primary outcome will be the ability to perform day to day activities of well trail drug (Vishnu chakra mathirai) on pakkavatham .the secondary outcome will be the evaluation of siddha diagnostic parameters .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.willing for admission and study in IPD for 40 days or willing to attend OPD.
- •2.Inability/difficulty to use upper/lower limb of one side.
- •3.willing to sign in the informed consent form.
排除标准
- •1.Age:Below 15 and above 60 2.Pregnant and lactating women 3.known h/o hypersensitivity or allergy to drug ingredients 4.Renal failure 5.Cirrhosis of liver 6.Cardiac diseases.
结局指标
主要结局
Ability to perform day to day activities well.
时间窗: 48 days
次要结局
- Evaluation of siddha diagnostic parameter(48 days)