A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of Pancha Lavana Mezhugu in the management of Azhal Keel Vaayu (Osteoarthritis of knee)
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 AZHAL keel vaayu
研究概览
简要总结
This is A PROSPECTIVE OPEN LABELLED, SINGLE ARM NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF PANCHA LAVANA MEZHUGU IN THE MANAGEMENT OF AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The trail drug PANCHA LAVANA MEZHUGU is freshly prepared and will be administrated at the dosage of 0.6 to 1.2g twice a day with hot water for 40 days. The trail period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai,Tirunelveli-627002,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of the trail drug PANCHA LAVANA MEZHUGU. The secondary outcome will be the evaluation of siddha diagnostic parameters(including envagai thervu) changes and thegi in azhal keel vaayu during the study period and collect various aspects of azhal keel vaayu in Siddha literature.
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
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients Presenting with joint pain 2.Morning stiffness for less than 30 minutes 3.Crepitus on active movement
- •Joint line tenderness
- •Difficulty in range of motion
- •Patients Presenting with or without swelling.
排除标准
- •Patients with history of trauma and post trauma
- •Ligament tear
- •Patients undergone knee replacement surgery
- •Metabolic joint disease
- •Infectious joint disease
- •Inflammatory arthritis (RheumatoidArthritis)
- •Septic arthritis
- •Osteomyelitis
- •Chronic liver and renal disease
- •Malignancy.
结局指标
主要结局
The outcome will be aimed at reducing the symptoms of AZHAL keel vaayu
时间窗: 40 days
And to determine the effectiveness of pancha lavana mezhugu.
时间窗: 40 days
次要结局
- 1. To collect various aspects of AZHAL keel vaayu in Siddha literature(2.to evaluate siddha parameters (including Envagai thervu) changes and thegi in azhal keel vaayu during the study period)