Evaluation of comparative efficacy of Ashwagandha versus Shallaki in chronic knee pain among older adults with knee osteoarthritis – A double-blind randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in score of Numeric Pain Rating Scale
研究概览
简要总结
This is a double blind randomized controlled study to determine the efficacy of Ashwagandha and Til taila abhyanga in chronic musculoskeletal pain associated with knee osteoarthritis among the elderly. The trial will be conducted as post-doctoral research as per the ICMR Bio-ethics guidelines. Total sample size that will be recruited in the trial is 72. The participants will be allocated to either group in 1:1 ratio. The trial arm will be compared with the control arm that will receive Boswellia serrata extract along with Til taila Abhyanga. The treatment duration will be for 6 weeks and follow-up will be by-weekly. The comparison of outcomes will be done at baseline and at the end of 6th week in both arms and between the groups.
This study might be useful to explore the effects of a balya and rasayana medicine in alleviating symptoms and improving the functionality of the older adults suffering with chronic knee pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants having pain in one or both knee joints since more than three months Average severity of knee pain in the past week is reported more than four when assessed through Wong-Baker Faces Participants scoring more than three in the Mini-Cog scale Diagnosed cases of Knee osteoarthritis (OA) or those who fulfil the clinical American College of Rheumatology (ACR) criteria for knee osteoarthritis Able to give written informed consent.
排除标准
- •Non-ambulatory patients Participants showing severe osteoarthritis on radiological evaluation and eligible to be categorized as Grade-4 of Kellgren and Lawrence scale for OA (Antero-posterior X-Ray of the affected knee showing large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends) History of treatment with intra-articular injection of corticosteroids or hyaluronic acid or oral corticosteroids within a period of three months preceding study Patients on regular intake of Ayurveda medicines (including any Ayurveda procedures) or physiotherapy (including therapeutic exercises) for pain relief in the past 2 weeks Patients having unilateral/bilateral fixed flexion deformity in knees or metallic implant in knee joint; or severe deformity of lower limbs (e.g., knee varus or knee valgus) History of knee joint replacement.
结局指标
主要结局
Change in score of Numeric Pain Rating Scale
时间窗: Baseline; at the end of Week 2, Week 4 and Week 6
次要结局
- KOOS(range of motion of the affected knee joint(s))