CTRI/2024/03/063534尚未招募4 期
A Comparative study on efficacy and safety of N-Acetyl Cysteine as an add on therapy with standard therapy in patients with Rheumatoid arthritis- A Randomised Open Labelled Prospective study.
Government Kilpauk Medical College1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年3月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Disease activity assessed using DAS 28 ESR score and CRP
研究概览
简要总结
This study is aimed to assess the safety and efficacy of N acetyl- cysteine as an add on therapy with standard therapy in patients with Rheumatoid arthritis.Patients with Rheumatoid arthritis fulfilling the inclusion criteria will be included in the study.All the participants will be assessed for DAS28 ESR score & CRP at baseline , 12 weeks and safety parameters using CBC,RFT,LFT,RF,CRP at baseline , 4,8,12,16 weeks
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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed as rheumatoid arthritis within 2 years by ACR criteria and having DAS 28-ESR score more than 3.2 who are not responding to standard therapy.
排除标准
- •Newly diagnosed Rheumatoid arthritis patients having DAS 28-ESR score less than 3.2 History of Psychiatric illness or drug abuse History of seizure disorder.
- •Known case of hypersensitive to N acetyl cysteine.
- •Pregnant and lactating females History of any autoimmune disease other than rheumatoid arthritis Patient taken biological agent therapy in last 6 months Patients taking N acetyl cysteine for any other cause.
结局指标
主要结局
Disease activity assessed using DAS 28 ESR score and CRP
时间窗: at baseline and 12 weeks
次要结局
- particpants will be assessed by CBC,LFT, RFT,CRP, ESR, RF(at baseline , 4 ,8,12, 16 weeks)
研究者
Dr S Meena
Government Kilpauk Medical College
研究点 (1)
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