A prospective open labelled single arm non-randomized single centricphase II clinical trial to determine the effectiveness of Rashnadi Chooranam in the management of Kumbavatham(Periarthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome will be aimed at reducing the symptoms of Kumbavatham(Periarthritis)and to determine the therapeutic efficacy of clinical trials drug(Rashnadi chooranam)
研究概览
简要总结
The study is a prospective open labelled single arm non randomized single centric phase II non randomized clinical study to evaluate the therapeutic efficacy of RASHNADI CHOORANAM in the management of KUMBAVATHAM(PERIARTHRITIS).The trial drug will be administered at the dose of 2g twice a day orally after food for 45 days in 40patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital,palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be to determine the therapeutic efficacy of RASHNADI CHOORANAM in the management of KUMBAVATHAM (PERIARTHRITIS).
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 pain, numbness ,wasting in the shoulder region and arms, restricted movement of the upper limbs, loss of abduction &forward flexion, stiffness of the shoulder joint.
- •Diabetes mellitus.
排除标准
- •Age: below 29 to above 61 years Rheumatoid arthritis Ischaemic heart diseases Pregnancy and lactating mother Recent shoulders dislocation.
- •Recent shoulder fracture.
结局指标
主要结局
The outcome will be aimed at reducing the symptoms of Kumbavatham(Periarthritis)and to determine the therapeutic efficacy of clinical trials drug(Rashnadi chooranam)
时间窗: 45 days
次要结局
- Evaluation of additional effects and siddha parameters changes in kumba vatham