Efficacy of Varmam Therapy for the Management of Osteoarthritis (Knee Joint)- An Open Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME
研究概览
简要总结
Osteoarthritis (OA) is a degenerative, non-inflammatory condition, characterized by destruction of articular cartilage and formation of bone in the joint space.In India 62.35 million people affected in 2019, women are most affected then men. It is 20th common cause of years living with disabilities in India. OA was estimated to be the 10th leading cause of nonfatal burden. The gastrointestinal toxicity, associated cardiovascular, renal risks are the major complications in pharmacological management and also the optimum duration of NSAID therapy is unclear. In topical application of NSAIDs and capsaicin are associated local adverse effects including rash, burning and itching. Intra-articular corticosteroid injections provide short-term pain relief. However, intra articular injections given more frequently than once every four months can result in cartilage and joint damage, as well as increased risk of infection, The American College of Rheumatology, the National Institute for Health and Clinical Excellence and the European League Against Rheumatism recommend non-pharmacologic modalities for the management of knee and hip OA. In Siddha system of medicine, has lot of the literature-based evidence in the management of Osteoarthritis also Pharmacological (Internal, External medicines), Non-Pharmacological (External therapies), in spite of the evidence for its effectiveness is unsatisfactory. The aim of the study is to evaluate the therapeutic efficacy of Varmam therapy.In this study, sample size 100, 11 varmam points are administered to each patient, administration time is 20-25 mins, total number of stimulation of Varmam points - 7 times for each varmam, duration of the study is 1 yr and 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 having symptoms of arthritis of one or both knee joints, pain, swelling, stiffness, crepitation, restricted movements of knee joint.
- •Patients who are willing to undergo radiological investigation, laboratory investigations.
- •Patients willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 160 days but can opt out of the trial of his/her own conscious discretion.
排除标准
- •H/o Cardiac diseases H/o Rheumatoid arthritis H/o Pregnancy and lactation H/o Chronic kidney disease H/o Tuberculosis of knee H/o Septic arthritis H/o Gonococcal arthritis H/o Traumatic pain of knee joint H/o Patient with any other serious systemic illness.
结局指标
主要结局
PRIMARY OUTCOME
时间窗: PRIMARY OUTCOME | To Assess the improvement of Santhuvatham (Osteo Arthritis–Knee joint) by reduce at least 2 or 3 scales from start to end of the study in KOO scale in the duration of 3 months (total number of sessions-36) in each patient, the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions
To Assess the improvement of Santhuvatham (Osteo Arthritis–Knee joint) by reduce at least 2 or 3 scales from start to end of the study in KOO scale in the duration of 3 months (total number of sessions-36) in each patient, the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions
时间窗: PRIMARY OUTCOME | To Assess the improvement of Santhuvatham (Osteo Arthritis–Knee joint) by reduce at least 2 or 3 scales from start to end of the study in KOO scale in the duration of 3 months (total number of sessions-36) in each patient, the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions
次要结局
- SECONDARY OUTCOME(To Assess the mental status before & after the varmam therapy management by Patient Health Questionnaire-9 [PHQ-9] & Brief Illness Perception Questionnaire [B-IPQ] in the duration of 3 months (Total number of sessions-36) in each patient. the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions.)
研究者
Uthrapathi S
Tamil University
