An open labelled randomised controlled parallel group clinical study to evaluate the efficacy Of PRASARINI SANDHANAM in management of AMAVATA W.S.R TO RHEUMATOID ARTHRITIS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in General Functional Capacity
研究概览
简要总结
Rheumatoid Arthritis is one of the common autoimmune diseases affecting 0.8 - 1% of adult population in society. It is the most common form of chronic inflammatory arthritis and often results in joint damage and physical disability. Treatment given in contemporary science are DMARD, NSAID, glucocorticoids which results in many complications on long term use like nausea, diarrhoea, vomiting, stomatitis, mood swings etc:-. Hence effective management is to be explored. Simhanada Guggulu which is proven to have effective results in management of Rheumatoid arthritis is taken as controlled group. Its efficacy is compared with Prasarini Sandhanam which is having drugs like Gandha prasarini, lacuna, panchakola and guda. This new formulation is taken for trial group and is expected to have better results due to its anti arthritic and anti inflammatory properties of drugs.
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To evaluate effect of prasarini sandhanam in management of Amavata w.s.r to Rheumatoid Arthritis
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To re-evaluate effect of Simhanada Guggulu in management of amavata w.s.r to Rheumatoid Arthritis
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To compare the efficacy of Prasarini Sandhanam and Simhanada Guggulu in management of amavata w.s.r to Rheumatoid Arthritis.
Null Hypothesis H0 - Efficacy of Prasarini Sandhanam is equal to efficacy of Simhanada Guggulu in management of Amavata w.s.r to Rheumatoid Arthritis
Research Hypothesis H1 - Efficacy of Prasarini Sandhanam is not equal to efficacy of Simhanada Guggulu in management of Amavata w.s.r to Rheumatoid Arthritis
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
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to give informed consent for research
- •Subjects who satisfy 4 criteria out of 7 of ARA
- •Subjects with classical signs and symptoms of Amavata.
排除标准
- •Subjects suffering from Rheumatoid arthritis secondary to any systemic diseases
- •Patients on any other medications like DMARD, NSAID, Corticosteroids
- •Patients having complications like swan neck deformity, ulnar deviation and any other diseases which interfere with the course of disease and treatment will be excluded.
结局指标
主要结局
Improvement in General Functional Capacity
时间窗: On 45th day the assessment will be done
次要结局
- To elicit the Quality of Life in patients with Amavata w.s.r to Rheumatoid Arthritis(15th, 30th, 45th day)