CTRI/2019/08/020779尚未招募2 期
Phase II non randomized open clinical evaluation of Siddha drug "SANMUGA MEZHUGU" for vathathambam (sciatica) - in both gender age between 25 TO 60 years patients attending opd at AAGHIM attached with GSMC.
Government Siddha medical college1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary outcome of treatment is mainly assessed by reduction in clinical symptoms measured by using Roland-Morris disability scale
研究概览
简要总结
This is a Non randomized open clinical trail to study the safety and efficacy of Siddha drug Sanmuga mezhugu. The drug is given 100mg twice a day for 35 days with intermittent 7 days gap. Clinical trail is conducted after conducting Pre clinical toxicity study. The trail drug Sanmuga mezhugu is mentioned in Anuboga vaithya navaneetham part 7. During the trail all the study related data will be recorded and documented. After the completion of trail all the data will be analysed statistically.
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
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having pain in the low back or leg Burning or tingling sensation present in the posterior and lateral aspect of the leg Weakness, numbness and difficulty in moving the leg or foot A constant pain on one side of the back A positive SLR test.
排除标准
- •Fracture of vertebrae Dislocation of vertebrae Deformities and congenital defects Known case of tuberculosis of spine Known case of neoplasm of spine Pregnancy and lactating women Multiple myeloma Patients of age below 25 above 60 years.
结局指标
主要结局
Primary outcome of treatment is mainly assessed by reduction in clinical symptoms measured by using Roland-Morris disability scale
时间窗: 35 days with intermittent 7 days gap
次要结局
- Secondary outcome of treatment is assessed by comparing the safety parameters before and after treatment(35 days with intermittent 7 days gap)
研究者
研究点 (1)
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