Effect of Ayurveda Management protocol on Rheumatoidarthritis-ARandomized Control Clinical Trialâ€
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- DAS 28 Score, ACR
研究概览
简要总结
Assessment of individual therapeutic responses provides valuable information concerning treatment benefits in individual patients. We evaluated individual therapeutic responses as determined by the Disease Activity Score-28 joints critical differ ence for improvement (DAS28-dcrit) in rheumatoid arthritis (RA) patients treated with intravenous tocilizumab or comparator anti-tumor necrosis factor (TNF) agents. The previously published DAS28-dcrit value [DAS28 decrease (improvement) ≥ 1.8] was retrospectively applied to data from two studies of tocilizumab in RA, the 52-week ACT-iON observational study and the 24-week ADACTA randomized study. Data were compared within (not between) studies. DAS28 was calculated with erythrocyte sedimentation rate as the inflammatory marker. Stability of DAS28-dcrit responses and European League Against Rheumatism (EULAR) good responses was determined by evaluating repeated responses at subsequent timepoints.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Dignosed as per ACR Criteria Either Sex Age group 20-60 years Patient fit for basti procedure.
排除标准
- •Chronicity of more than 10 years
- •Having severe crippling deformity
- •Patients with uncontrolled systemic illness like hypertension and diabtes, cardiac illness etc.
结局指标
主要结局
DAS 28 Score, ACR
时间窗: at every follow up 9,14,28,45,60
次要结局
- DAS 28, ACR Criteria, RA titer, IL6(0th & 60th day(RA titer, IL6))
研究者
Dr Shruti Ramesh Tarapure
Department of Kayachikitsa(General Medicine)