NCT03025399

Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy

Multi Center Clinical Study of Chinese Medicine Intervention on Early Diabetic Microvascular Complications: Multi Centers Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Fengmei Lian · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study include 384 Participants with diabetic non-proliferative retinopathy Design Method: Randomized, double blind, placebo controlled and multicenter clinical study. Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of tang wang prescription improve degree of retinal microvascular disease of patients with diabetic non-proliferative retinopathy.

Detailed description

1. This study is a randomized, double-blinded, placebo-controlled and multicenter clinical trial on type 2 diabetic non-proliferative retinopathy to evaluate the therapeutic effect of tang wang prescription. 2. Through the calculation of sample size, 384 participants with type 2 diabetic non-proliferative retinopathy will be recruited for the study, all participants were randomly divided into 2 groups, and both of groups would be performed on a basic treatment (including diabetes education, diabetes diet, rational control of blood glucose (oral hypoglycemic agents or insulin injections to keep all participants keep blood glucose stable in the study. If fasting blood glucose fluctuates more than 20%, need to find and remove the factors as soon as possible, and adjust the dose and monitor change of blood glucose, make it smooth in 4 weeks. Adjusted dose of the drug needs to be detailed records in the combined medication table), and oral calcium dobesilate treatment), study group take tang wang prescription, take one bag each time and twice on day, control group take the same dose of placebo. 3. The study will last for 48 weeks. Once every four weeks follow-up, color fundus photography, fundus fluorescein angiography, and coherent optical tomography were performed every six months; ETDRS international visual acuity test was performed every months. 4. Curative effect evaluation criteria: * Main evaluation criteria: the changes of degree of retinal microvascular lesions before and after treatment, according to the change of degree of retinal microvascular lesions (no, mild non proliferative phase, moderate non proliferative phase, severe non proliferative phase, proliferative phase), divided into aggravated, unchanged, reduce three conditions. Aggravated was defined as the degree of retinal microvascular lesions severity more than grade 1 after treatment; unchanged was defined as the degree of retinal microvascular lesions before and after treatment did not change; reduce was defined as the degree of retinal microvascular lesions reduced more than 1 grade after treatment. * Second evaluation criteria: * Change of the number of micro hemangioma of diabetic retinopathy before and after treatment; * Change of the number of microvascular bleeding of diabetic retinopathy before and after treatment; * Change of the number of microvascular leakage of diabetic retinopathy before and after treatment; * Degree of change of macular edema of diabetic retinopathy before and after treatment; * Change of Vision before and after treatment. 5. Diagnostic and monitoring indicators：blood pressure, fasting blood glucose test (every one month); glycated hemoglobin, blood lipids (every three months); Routine eye examination and fundus examination, including intraocular pressure, anterior segment, lens, vitreous body, and lens, vitreous need describe the conditions of opacity (every six months). 6. The provisions of the combined therapy * All Chinese herbal medicines with the same efficacy as the study drug (including Chinese herbal medicines with similar therapeutic and similar efficacy in Instructions) were banned during the study period. * All combined therapy and Combined medication(treatment measure or treatment medicine of other diseases) should be recorded in the combined medication table.

Conditions

• Diabetic Non-proliferative Retinopathy
• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	Tangwang prescription	A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.
DRUG	Placebo	Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-05-01
• Completion: 2020-05-01
• First posted: 2017-01-19
• Last updated: 2017-01-20