An open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy)in the management of Azhal keel vayu (osteoarthritis of knee joint)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in severity of joint pain,stiffness and improvement in joint movements,physical functioning and quality of life
研究概览
简要总结
This study was an open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy)in the management of Azhal keel vayu (osteoarthritis of knee joint).The trail drug procedure will be given for one time in a day at an interval at an 3-7 days upto 3-7 Kattu for 21 days in 40 patients.The trial drug will be carried out in Government siddha medical College and hospital, palayamkottai,Tirunelveli 627002.The outcome will be Reduced severity of joint pain,Stiffness and improvement of joint movements and quality of life.In case of any adverse events was noticed and it will be referred to pharmacovigilence department.Further management of patients will be given OPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having symptoms of 1.Pain in single or both knee joints 2.Swelling 3.Tenderness 4.Stiffness 5.Crepitation 6.Restricted movements Patients who are willing to undergo Kattu (Bandage in siddha external therapy) Patients who are willing to give specimen of blood for investigation whenever required.
- •Patients who are willing to attend OPD or admission in IPD for 21 days.
- •Patients who are willing to take external therapy along.
排除标准
- •History of tuberculosis History of hepatitis B,AIDS,Syphilis.
- •History of Haemophilia & anticoagulant treatment.
- •Rheumatoid and other types of arthritis.
- •Trauma, fracture,ligament injury.
- •History of psychiatric disorder.
- •Surgery of the affected knee joint during the previous 3 month or joint replacement.
结局指标
主要结局
Reduction in severity of joint pain,stiffness and improvement in joint movements,physical functioning and quality of life
时间窗: 21 days
次要结局
未报告次要终点
研究者
DrRAnand
Government siddha medical College and hospital, Palayamkottai.