A randomized controlled trial to evaluate the efficacy of multimodal Ayurveda interventions in Jaanu Sandhigatavata (Primary Knee Osteoarthritis)

Central Council for Research in Ayurvedic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•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
•Bony tenderness
•Bony enlargement
•No palpable warmth

•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/mÂ²
•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 participantâ??s safety or compliance, interfere with evaluation or preclude completion of the study

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