Clinical Study on the Efficacy and Safety of Tangningtongluo Tablet in Treating Non Proliferative Diabetic Retinopathy - The Syndrome of Yin Asthenia Generating Intrinsic Heat and Eye Collateral Stasis

TNTL-21-01

This trial is planned to collect relevant clinical data to evaluate the prevention efficacy and safety of Tangningtongluo tablets on the non-proliferation period of diabetic retinopathy.

2021-08-31

2023-10-31

2023-12-31

Active (not recruiting)

Early phase I

240

Inclusion Criteria: * 1. Patients with the diagnosis of type 2 diabetes. * 2. Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate. * 3. Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1). * 4. Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine. * 5. HbA1C ≤ 9%. * 6. Age between 18 and 75 years old * 7. Informed consent, voluntary subject. The process of obtaining informed consent form complies with Good Clinical Practice(GCP). Exclusion Criteria: * 1. Patient with the diagnosis of diabetic retinopathy is combined with severe vitreous blood effusion, or required total retinal laser treatment or vitrectomy. * 2. Patient who has been treated with full retinal laser photocoagulation. * 3. Patient with difficulty in evaluating fundus images with refractive medium turbidity. * 4. Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month. * 5. Patient with other serious diabetes complications, such as diabetes gangrene. * 6. Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition. * 7. Female patient with pregnancy, or prepare for pregnancy, or lactating. * 8. Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases. * 9. Liver and renal function (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 x Upper limit of normal (ULN)and Cr\> above 1 x Upper limit of normal (ULN)). The diabetic nephropathy stage was 4 and above. * 10. Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract. * 11. Patient participated in other clinical researches within a month.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ACTUAL'}}

2023-05-09