CTRI/2021/02/031214尚未招募2 期
A Prospective Open labelled non randomized phase II Clinical trial of Sathakuppai Chooranam in the management of Kumba vatham(Periarthritis)
Government Siddha Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月27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
- 60
- 试验地点
- 1
- 主要终点
- Reduction of the signs and symptoms of shoulder joint pain
研究概览
简要总结
The study is a prospective Open Labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of Sathakuppai Chooranam in the management of Kumba Vatham(Periarthritis).The trial drug will be administered at the dose of 1g twice a day orally aftert food for 45days in 60 patients.The trial period of 12 months will be carrying out in government Siddha Medical College And Hospital,Palayamkottai,Tirunelveli,Tamilnadu.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having main symptoms of shoulder joint,numbness,wasting in the shoulder region and arms ,restricted movement of upper limbs,loss of abduction&forward flexion,stiffnees of the shoulder joint Diabetes mellitus.
排除标准
- •Age below 29&above 61 Rheumatoid Arthritis Ischemic heart Disease Hypertension Pregnancy and lactating mother Recent Shoulder dislocation Sub acromial bursitis.
结局指标
主要结局
Reduction of the signs and symptoms of shoulder joint pain
时间窗: 45 days
Numbness
时间窗: 45 days
Wasting in the shoulder region and arms
时间窗: 45 days
restricted movement of the upper limbs
时间窗: 45 days
loss of abduction
时间窗: 45 days
loss of forward flexion
时间窗: 45 days
stiffness of the shoulder joint
时间窗: 45 days
次要结局
- Evaluation of additional effects and siddha parameters changes in Kumba vatham(45 days)
研究者
研究点 (1)
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