Comparing individualized homoeopathy with placebo in managing pain of knee osteoarthritis: a double blind randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in pain, stiffness, limitation of movement on an identified scale
研究概览
简要总结
Thestudy will be conducted with an objective to compare the efficacy of individualized homoeopathictreatment with placebo in pain management of knee joint osteoarthritis. 200 patientsabove the age of 50 years diagnosed with knee osteoarthritis (as per ACRcriteria) will be enrolled in the study. Study is a multi-centric double blindplacebo controlled trial, where individualized homoeopathic medicine/ placebowill be given and patient will be assessed every 2 weeks for 2 months. The regularmedications of the patients, if any will continue throughout the period oftrial. Outcome will be measured in terms of change in knee pain, stiffness,limitation of movement and use of NSAIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above the age of 50 years, presenting with knee pain and evidence of osteophytes in the knee radiograph.
排除标准
- •â€¢Rheumatoid factor more than 1:40 titre •ESR more than 40mm/hour •Serum uric acid level >7 mg/dL in men or >6 mg/dL in women •Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (> 12°); evidenced by imaging or other evidences and requiring surgical intervention •Non-ambulant patients •Self-reported joint disorders (e.g. inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs) other than OA •IA injections within 2 weeks prior to study entry •Cases with other systemic unevaluated or uncontrolled diseases like diabetes mellitus, hypertension, or other cardiovascular, renal, gastro-intestinal, endocrinal, gynecological diseases etc.
- •or systemic infections affecting quality of life or on other treatment therapies •Psychiatric illness •Patients with any vital organ failure •Recent knee surgery within last 6 months •Cases with transplanted knees •History of homeopathic treatment for any chronic disease within last 6 months •Self-reported immune-compromised states •Alcohol and/or drug addiction or dependence •Cases with controlled/uncomplicated hypertension, diabetes mellitus, etc.
- •will not be excluded.
- •Patients on life-saving conventional drug therapies, e.g. anti-diabetics, anti-hypertensives, thyroid drugs etc.
- •for co-morbidities under control, will be continued.
结局指标
主要结局
Change in pain, stiffness, limitation of movement on an identified scale
时间窗: every 15 days till 2 months of treatment
Change in pain measured on identified scale (OARSI - OMERACT constant/intermittent pain measure)
时间窗: every 15 days till 2 months of treatment
次要结局
- Change in requirement of NSAIDs during the course of treatment(•Incidence of any adverse events/severe adverse events during the period of treatment)