An open lebel randomized clinical study to evaluate the comparative efficacy of Matra basti with Prasarani taila and Prasarani taila pana in the management of Janusandhigatavata w.s.r to osteoarthritis of knee joint
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in WOMAC total score
研究概览
简要总结
The trial is a open label randomized clinical trial. The primary aim of the trial is to compare the efficacy of Matra basti( ( a form of oily enema) with Prasarini Taila(oil) and efficacy of oral intake of Prasarini taila ( oily) in the management of Janusandhigatavata w.s.r. to osteoarthritis of knee joint. Total 60 patient will be taken for trial. The patient will be randomly divided into two groups of 30 patients each. In group A Matra basti with Prasarini taila will be done for 14 days .In group B oral intake( Taila Pana) of Prasarini taila in the dose of 20ml twice a day for 14 days . The primary outcome will be the improvement in total score of WOMAC osteoarthritis index.The patient will be finally assessed after one month of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •(1)Patients with the clinical features of Janu-Sandhigata Vata (Osteoarthritis of knee joint).
- •(2)Patients fit for Matra Basti and Taila Pana.
- •(3)having symptoms of OA (above 3 months and maximum 10 years confirmed by radiological changes as per grade I to III of Kellgren & Lawrence radiological scale and diagnosed as per American college of Rheumatology diagnostic criteria for OA of the knee) and willing able to participate in the study for 04 weeks.
排除标准
- •(1)Patients having developed deformity.
- •(2)Patients with severe form of systemic disorders.
- •(4)Associated with simple or compound fractures.
结局指标
主要结局
Changes in WOMAC total score
时间窗: One month
次要结局
- Evaluate the changes in the score of three sub scales i.e.(WOMAC Pain subscale, WOMAC Stiffness subscale, WOMAC physical)