Comparison of efficacy of Kottamchukkadi Upanaha in two different time duration in Primary Osteoarthritis knee-a Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- WOMAC score
研究概览
简要总结
A randomized controlled non inferiority trial is planned to asses efficacy of Kottamchukkadi upanaha done for 3 hours and 12 hours duration in reducing WOMAC total score in Primary Osteoarthritis knee. 54 participants fulfilling the criteria will be taken for the study . They will get allocated to two groups by computer generated randomization. Participants in group A will be given upanaha for 3hours and group B for 12 hours. Primary assessment will be done with WOMAC total score on 0th and 8th day after treatment. Secondary assessments will be done with VAS scale ranging from 0 to 100mm and safety by Event evaluation scale which will be done on every day and range of movements using Goniometer which will be done on 0th and 8th day.
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
- •Participants fulfilling the American College of Rheumatology clinical classification criteria of knee OA Radiological findings of knee of grade 2 to 4 in Kellgren Lawrence Grading scale Fit for upanaha Participants with features of associated ama or kapha Participants willing to give informed consent.
排除标准
- •Known cases of RA and other types of arthritis Known cases of fracture/ligament tear/dislocation/knee joint infection/malignancy Known cases of dermatological disorders Uncontrolled Diabetes mellitus FBS greater than or equal to 126 mg/dl on medication Body mass index greater than equal to 40 kg/m2 Pregnant and lactating women.
结局指标
主要结局
WOMAC score
时间窗: 0th and 8th day after treatment
次要结局
- VAS ranging from 0 to 100mm(Safety by Event evaluation scale)
- Range of movement using Goniometer(0th and 8th day after treatment)
研究者
Dr Sinjith K P
Vaidyaratnam P S Varier Ayurveda college Kottakkal