/ Not yet recruitingPhase 3 糖宁通络片治疗糖尿病视网膜病变非增殖期(阴虚内热、目络瘀阻证)的有效性及安
全性Ⅲ期临床研究
[Translation] Phase III clinical study on the effectiveness and safety of Tangning Tongluo tablets in the treatment of non-proliferative diabetic retinopathy (yin deficiency, internal heat, eye meridian stasis syndrome)
1. 观察糖宁通络片改善视力、降低视网膜病变程度有效性;
2. 观察糖宁通络片临床使用的安全性。
[Translation] 1. To observe the effectiveness of Tangning Tongluo Tablets in improving vision and reducing the degree of retinopathy;
2. To observe the safety of Tangning Tongluo Tablets in clinical use.
Phase III Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy(With Syndrome of Yin Deficiency With Internal Heat and Blood Stasis Obstructing the Collaterals of the Eyes)
The goal of this clinical trial is to learn if drug TNTL works to treat non-proliferative diabetic retinopathy in adults. It will also learn about the safety of drug TNTL. The main questions it aims to answer are:
1. Does drug TNTL can improve visual acuity and reduce the degree of retinopathy?
2. What medical problems do participants have when taking drug TNTL? Researchers will compare drug TNTL to a placebo (a look-alike substance that contains no drug) to see if drug TNTL works to treat non-proliferative diabetic retinopathy.
Participants will:
1. Take drug TNTL or a placebo every day for 6 months
2. Visit the clinic once every 4 weeks for checkups and tests
3. Keep a diary of their symptoms and Change from baseline
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