Cardioprotective Benefits of Methotrexate and Hydroxychloroquine Combination Therapy vs Methotrexate Monotherapy in Early and Low Risk Rheumatoid Arthritis A Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Comparing the cardioprotective benefits between the two groups.
研究概览
简要总结
The study aims to study the effect of Methotrexate and Hydroxychloroquine Combination Therapy vs Methotrexate monotherapy and their role as a cardioprotective agent in Early and Low risk rheumatoid arthritis patients. It is a randomized control study. The study will assess changes in CRP, ESR, Lipid Profile and Blood Glucose changes at baseline, 1 month, 3 months and 6 months. A total of 66 patients will be recruited where 33 will be assigned to Group 1 which will receive Methotrexate Monotherapy and 33 will be assigned to Group 2 and will receive Methotrexate and Hydroxychloroquine Combination therapy. Both groups will be followed up and will be monitored for potential cardioprotective changes in the respective groups. The goal is to know whether initiation of combination therapy early in rheumatoid arthritis has any cardioprotective benefits or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Clinically Diagnosed patients with Rheumatoid Arthritis fulfilling the EULAR Criteria more than 6
- •Early Rheumatoid Arthritis less than 2 years and Low Risk Rheumatoid Arthritis.
- •DAS28 less than 3.2
- •Adult patients of the age of 18 to 60 years.
- •All Genders.
- •Participants willing to give informed consent.
排除标准
- •Pregnant and Nursing women.
- •Patients with history of cardiovascular complications like MI, CVA and Heart Blocks and abnormal ECG changes.
- •Patients using lipid lowering drugs.
- •Patients on medications that can prolong the QT interval.
- •Patients with other autoimmune diseases.
- •Impaired renal and liver functions.
- •Patients with joint deformities.
- •Patients with Retinal defects.
结局指标
主要结局
Comparing the cardioprotective benefits between the two groups.
时间窗: 1. Baseline | 2. 1 Month | 3. 3 Months | 4. 6 Months
次要结局
- Safety and Efficacy of drugs used in both groups.(1. Baseline)
研究者
Dr Cyrus Paul Isaac
Shri Atal Bihari Vajpayee Medical College and Research Institute