CTRI/2019/05/019238尚未招募不适用
A Clinical Study On The Combined Effectiveness Of Shatyadi Kalka With Varshabhu Kashaya As Anupana And Vaitarana Basti In Amavata (Rheumatoid Arthritis)
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease Activity Score of 28 joints
研究概览
简要总结
This study is a open label, single arm, exploratory clinical study assessing the effectiveness of Shatyadi Kalka 12 gm daily with Varshabhu Kashya 50 ml daily (in divided doses) (24 days) with therapeutic enema – Vaitarana Basti in Yoga Basti schedule for first 8 days. The study is conducted in Hospital attached to Ayurveda medical college with laboratory facilities. The primary outcome measure is disease activity score at 28 joints on 24th day and secondary outcome measure is ESR and early morning joint stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
入选标准
- •Inclusion Criteria 1.Rheumatoid Arthritis Diagnosed On The Basis Of 2010 ACR EULAR Criteria.
- •2.Subjects Aged Between 18-70 Years.
- •3.Subjects Of Either Gender.
- •4.Subjects Who Are Fit For Bastikarma.
- •5.Subjects Willing To Participate In Study And Ready To Sign The Informed Consent.
- •Laboratory Investigations 1.Rheumatoid factor(R.A.Factor) 2.Erythrocyte sedimentation Rate(E.S.R).
排除标准
- •Exclusion Criteria 1.Subjects With Known Case Of Uncontrolled Diabetes Mellitus And Essential Hypertension.
- •2.Subjects With Known Case Of Impaired Renal, Hepatic And Cardiac Function.
- •3.Pregnant And Lactating Woman.
结局指标
主要结局
Disease Activity Score of 28 joints
时间窗: 24 days
次要结局
- Early morning stiffness in minutes and Erythrocyte Sedimentation Rate
研究者
研究点 (1)
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