the Impact of Metformin Use on Clinical Outcomes in Gouty Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- - Clinical assessment of disease activity
研究概览
简要总结
The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.
排除标准
- •Systemic disorders such as cardiovascular, neurological, coronary artery disease.
- •Hypertension, hyperlipidemia, diabetes mellitus, active infections.
- •Other inflammatory or autoimmune diseases.
- •Patients on biologics,
- •Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.
研究组 & 干预措施
Control group
this group will receive placebo in addition to the traditional lines of treatment of gout.
干预措施: placebo (Other)
Metformin group
This group will receive metformin (1000mg/day) in addition to the traditional lines of treatment of gout.
干预措施: Metformin (Drug)
结局指标
主要结局
- Clinical assessment of disease activity
时间窗: 3 months
- Clinical assessment of disease activity by assessing patient and physician VAS visual analog scale (0-10 cm);
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Lecturer
Tanta University