Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- high sensitivity CRP and Endothelin-1 serum levels
研究概览
简要总结
Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BS 120-200 mg/dl
- •Age 40-70
- •Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)
- •type II diabetes
- •no history of doxium consumption
排除标准
- •Allergy to doxium
- •incidence of active hepatic disease or rising of hepatic enzymes during the intervention
研究组 & 干预措施
Placebo
Placebo tablets will be administered to the patients in Placebo arms daily for three months.
干预措施: Placebo drug (Drug)
Calcium dobesilate
Calcium dobesilate as 500 mg tablets will be administered once to the patients daily.
干预措施: Calcium dobesilate (Doxium) (Drug)
结局指标
主要结局
high sensitivity CRP and Endothelin-1 serum levels
时间窗: 3 month
次要结局
未报告次要终点