EVALUATION OF COMBINED EFFICACY OF AGNIKARMA AND SHALLAKI IN THE MANAGEMENT OF JANU SANDHIGAT VATA WITH SPECIAL REFERANCE TO KNEE JOINT OSTEOARTHRITIS: A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To evaluate the combined efficacy of Agnikarma and Shallaki versus Agnikarma and Shallaki alone in the management of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis.
研究概览
简要总结
This study is aim to evaluate the combined efficacy of Agnikarma and Shallaki versus Agnikarma and Shallaki alone in the management of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis, and objectives of this study are, to evaluate the efficacy of Shallaki and Agnikarma alone in reducing pain and improving joint function in Janu Sandhigat Vata for 30 days. To assess the combined efficacy of Shallaki and Agnikarma in managing Janu Sandhigat Vata for 30 days. To compare the combined efficacy of Shallaki and Agnikarma with their individual effects on pain relief and joint function in Janu Sandhigat Vata for 30 days. and secondary objective is to estimate the prevalence of wound infection at the Agnikarma site within trial period (30 days) using clinical assessment.
Randomly selected 99 patients fulfilling inclusive criteria will be divide in to 3 groups namely A, B, C. GROUP A: n=33 *Agnikarma will be performed at knee joint ,*GROUP B: n=33 Shallaki Niryas capsule, GROUP C: n=33 Agnikarma with Shallaki Niryas Capsule. Duration of therapy will be 30 days. with follow up 1st day, 7th, 14th, 21th day.
Outcome variables will be changes in the KOOS Scale and X- ray Knee joint (Kellgren-Lawrence Classification of Osteoarthritis)
This study will evaluate the combined efficacy of Agnikarma and Shallaki Niryas capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient suffering from Janu sandhigat vata w.s.r. to Knee joint osteoarthritis from 2 or less than 2 years will be selected for study.
- •Patient between the age group 45-60 years.
- •Patient will be selected irrespective of sex, religion, occupation, socioeconomic status after clinical diagnosis of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis as per international classification of disease ICD 11.10.
排除标准
- •Known case of Diabetes Melitus.
- •Known case of Spondylolisthesis.
- •Known case of R.A. •Known case of Osteosarcoma.
- •Known case of Tuberculosis of knee.
- •Known case of Diabetic neuropathy.
结局指标
主要结局
To evaluate the combined efficacy of Agnikarma and Shallaki versus Agnikarma and Shallaki alone in the management of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis.
时间窗: 1st day, 7th day , 14th day , 21th day,.
次要结局
- Changes in X ray and prevalence of wound infection after agnikarma(1st day, 7th, 14th, 21th day)