Clinical evaluation of Vatari guggulu, Maharasnadi Kwatha and Narayan taila in the management of Osteoarthritis knee.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Change in WOMAC total score
研究概览
简要总结
Thisis an open label interventional study for evaluating the safety and efficacy ofclassical Ayurvedic therapeutic regimen consisting of Vatari guggulu 500 mg 2tablets thrice a day, Maharasnadi kwatha 20 ml twice a day, local applicationof Narayan taila for 12 weeks in 180 patients with Osteoarthritis knee. Thetrial will be conducted in three centers. In this proposed study theeffect of this combination will beevaluated for clinical response and change in the quality of life by usingstandard parameters. The primary outcome measures will be change in WOMAC totalscore. The secondary outcomes will be change in WOMAC stiffness domain score, changein WOMAC physical function Domain, global assessment of disease activity, changein the visual analogue scale(VAS) for pain in last 48 hrs. and Ayurvedicdisease specific symptoms at the end of 14th day,28thday,42nd day,56th day, 70th day and 84thday and after 4 weeks of follow-up without the trial regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with Primary Osteoarthritis (knee) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology.
- •Pain in the affected joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale).
- •Willing and able to participate in the study for 16 weeks.
排除标准
- 未提供
结局指标
主要结局
Change in WOMAC total score
时间窗: at baseline,at 84th day and at the end of follow up after 16 weeks.
次要结局
- 1.Change in WOMAC stiffness Domain Score(2.Change in WOMAC Physical function Domain)