A Randomized, Double Blind, Multi-Center Study of Compound Danshen Dripping Pills in Patients With Diabetic Retinopathy (Syndrome Of Qi-Stagnation and Blood Stasis)
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 16
- 主要终点
- The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).
详细描述
Compound danshen dripping pills is a kind of traditional Chinese medicine(TCM), consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol. This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis), when compared with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
- •aged 30-70 years
- •voluntary signs the informed consent
- •One eye met the inclusion criteria can be used as research object, if both eyes met the inclusion criteria, please record respectively, and select one eye for efficacy evaluation with reference to the following principles:
- •When the two eyes of fundus conditions in different clinical stage, choose the more serious one.
- •When the two eyes of fundus conditions in the same clinical stage, choose the eye easier for clinical operation.
排除标准
- •HbAlc>8%, sustained hyperglycemia.
- •The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
- •Diabetic retinopathy caused by type 1 diabetes mellitus.
- •Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
- •Combined with primarily severe diseases such as cardiovascular, hepatic，renal illness , hemopoietic system disease, and psychosis. Serum transaminase is higher than the limit of normal value of 1.5 times.
- •Diabetic nephropathy with renal failure (Azotemia or Uremia).
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs.
- •Participated in other clinical trial within 3 months.
- •Used drugs for the treatment of diabetic retinopathy within 1 week.
- •Blood pressure > 160/100 (systolic above 160 or diastolic above 100).
研究组 & 干预措施
Compound danshen dripping pills
Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.
干预措施: Compound danshen dripping pills (Drug)
Placebo
Placebo,20pills,tid. Duration: 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo
时间窗: 24weeks
次要结局
- Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo(24 weeks.)
- Corrected visual acuity change from baseline at the end of week 24 compared to placebo(24 weeks.)
- The severity of macular edema change from baseline at the end of week 24 compared to placebo(24weeks)