A randomized controlled trial to evaluate the efficacy of multimodal Ayurveda interventions in Jaanu Sandhigatavata (Primary Knee Osteoarthritis)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in knee pain and functional disability from baseline assessed through WOMAC index score
研究概览
简要总结
Numerousclinical researches have been carried out to study the effect of variousAyurvedic management strategies for Sandhigatavata. However,most of the published studies dealt with selected modalities of treatmentrather than the holistic Ayurvedic line of management. Itis required to execute research studies with multimodal components of Ayurvedictreatment for Sandhigatavata (osteoarthritis) with long-term follow-upperiod. For this study, Panchkarma proceduresincluding MatraBasti and Janu Basti along with oral medications LakshaGuggulu and Muktashukti bhasma have been proposed for the management of Jaanu Sandhigatavata (Primary Knee Osteoarthritis) for aperiod of 180 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 40 to 70 years having diagnosed Knee osteoarthritis (OA) as per the ACR criteria with the following parameters will be included in the study: 1.Pain score of at least 2 (Numeric Pain rating scale) in most days of the last month; 2.American College of Rheumatology (ACR) functional status criteria class I, II and III 3.Serum vitamin D level of >30 ng/ml 4.Able and willing to give informed consent ACR criteria Pain in knee + Any 3 of the following: Age > 50 years Less than 30 minutes of stiffness Crepitus Bony tenderness Bony enlargement No palpable warmth.
排除标准
- •Patients with the following criteria will be excluded from the study: 1.Grade 4 and above radiographic changes in the affected knee (Kellgren-Lawrence classification) 2.Significant trauma to the knee including arthroscopy within preceding one year 3.History of knee joint replacement 4.BMI≥32 kg/m² 5.History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study 6.On corticosteroids 7.Rheumatoid arthritis, Psoriatic arthritis, Lupus 8.Uncontrolled HTN (>160/100 mm Hg) 9.Uncontrolled DM (HbA1c>8.0) 10.Cardiac, hepatic or renal function impairment 11.History or active malignancy 12.Tendency for occurrence of recurrent renal calculi 13.Hypersensitivity to trial drugs 14.History or active substance abuse/ alcoholism 15.Any contraindication for MRI scan 16.Any other condition that in the opinion of the investigator may compromise the participant’s safety or compliance, interfere with evaluation or preclude completion of the study.
结局指标
主要结局
Change in knee pain and functional disability from baseline assessed through WOMAC index score
时间窗: At baseline,30th day, 60th day, 90th day, 120th day, 150th day and 180th day.
次要结局
- 1.Change in score for pain, stiffness and physical function of WOMAC from baseline(2.Change in the range of motion of knee joint (assessed through goniometer))