A Prospective open labelled phase-II Non-randomized clinical trial on kodiveli chooranam for the tratment of Vali Azhal Keel Vayu(Rheumatoid Arthritis)
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
- 1.Reducing the pain, swelling, early morning stiffness, deformities.
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 KODIVELI CHOORANAM in the management of vali azhal keel vayu (Rheumatoid arthritis).The trial drug will be administered at the dose of 20mg/kg/Body weight BD before food along with water as adjuvant for 45 days in 40 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelveli TamilNadu. The Primary out come will be the evaluation of therapeutic efficacy of trial drug KODIVELI CHOORANAM . The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Symmetrical joint involvement 2.Involvement of 3 or more joints 3.Florid morning stiffness and swelling that lasts for few hours or days 4.Pain, joint swelling especially in the interphalangeal joints 5.Pain criteria score should be greater than or equal to 6.
排除标准
- •1.Psoriatic arthritis 2.Gout 3.Mixed connective tissue disorders 4.SLE 5.Extra pulmonary tuberculosis.
结局指标
主要结局
1.Reducing the pain, swelling, early morning stiffness, deformities.
时间窗: 45days
2.To assess improvement based on the disease activity pain score.
时间窗: 45days
次要结局
- 1.Evaluation of addition effects and siddha parameters during trial period(2.Determination of safety profile of trial drug)