CTRI/2018/09/015821已完成不适用
Evaluation of the effect of classical Ayurvedic treatment in the functional improvement of patients with Rheumatoid Arthritis
Ministry of AYUSH Government of India1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of classical Ayurvedic treatment in the functional improvement of patients with Rheumatoid Arthritis
研究概览
简要总结
The study is a open clinical trail conducted in Vaidyaratnam Ayurveda foundation, Thrissur, to evaluate the safety and efficacy of Ayurvedic management in Rheumatoid Arthritis ( Amavatam). The trail period is 57days which includes 21 days of IP Treatments and 21 days of OP Treatments followed by 15 days of follow up period. The target is 50 cases. The parameters for assessment includes Objective observations, subjective details, SF (36), DAS 28 Score for will be evaluated statistically.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with either sex with age between 20 to 60 years
- •Presence of any four out of the following seven criteria ( According to 2010, Revised criteria of American college of Rheumatology) a) Morning stiffness lasting more than 6 weeks b)Arthritis of three or more joints c) Arthritis of hands d) Presence of Rheumatoid nodules e) Symmetric Arthritis f) Serum Rheumatoid Arthritis/ ACCP positive g) Abnormal CRP/ESR
- •Patient willing to participate in the study for 57days.
排除标准
- •Patients who developed complications of Rheumatoid Arthritis
- •Patients who are unable to walk without support/ bedridden
- •Patients with poorly controlled Hypertension/ Diabetes/ Cardiac failure/ Hepatic disorder
- •Patients who are diagnosed with other arthritis
- •Alcoholics/ Pregnant woman/ Lactating Woman/ Hypersensitivity to drugs/ Prolonged medications.
结局指标
主要结局
Evaluation of the effect of classical Ayurvedic treatment in the functional improvement of patients with Rheumatoid Arthritis
时间窗: 1st, 7th,21st,42nd AND 57th day
次要结局
- To establish the safety of ayurvedic line of management in Rheumatoid Arthritis(One and half year)
研究者
研究点 (1)
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