Effect of nirgundi kwath and a herbal formulation in janu sandhigatvata (primary osteoarthritis of knee joint)- A placebo controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- X Ray of involved knee joint (Antero Posterior and Lateral View)-
研究概览
简要总结
In this trial we are selecting the patients of Primary osteoarthritis of knee in which we will do intervention in two groups (20 patients in each). In one group, we will intervene our ayurvedic preparation(Nirgundi kwath and a herbal formulation tablet) whereas in other group placebo will be given to the patients. Assessment should be done on the basis of assessment done before treatment, during. Follow up and post treatment as discussed earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient will be selected irrespective of Sex and socio-economic status.
- •Patients have fulfilling criteria for diagnosis of Janu Sandhigatavata such as Sandhishoola, Sandhishotha, Sparshashatva, Sandhisphutan.
- •40 to 65 years.
- •Patient with Controlled Diabetes.
- •Patient falling in Grade 1 and Grade 2 of Kellgren–Lawrence radiographic grading scale of osteoarthritis.
排除标准
- •Knee Osteoarthritis secondary to other conditions like Trauma, Fractures, Tuberculosis, malignancy, HIV, Cardiac disease, Neurological disorders, associated with Janu Sandhigatavata.
- •Patient with total knee joint replacement or complete loss of articular cartilage.
- •Patients having other systemic disorders which might interfere in the present study.
- •like Amavata (Rheumatoid Arthritis), Gout (Vatarakta), Severe bursitis.
- •Pregnant and lactating women.
- •Patient falling in Grade 3 and 4 of Kellgren–Lawrence radiographic grading scale of Osteoarthritis.
结局指标
主要结局
X Ray of involved knee joint (Antero Posterior and Lateral View)-
时间窗: Before intervention of the treatment
2. Radiography-I To diagnose the patients (at or before day 0) at the time of inclusion.
时间窗: Before intervention of the treatment
3. Radiography-II To be compared with Radiography-I at the time of final assessment
时间窗: Before intervention of the treatment
次要结局
- X Ray of involved knee joint (Antero Posterior and Lateral View)-(2. Radiography-I To diagnose the patients (at or before day 0) at the time of inclusion.)