Type2 Diabetes, Diabetic Retinopathy
Conditions
Keywords
Diabetes, Retinopathy, Tangningtongluo tablets
Brief summary
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.
Detailed description
After being informed about the study and potential risks,all patients giving written informed consent will undergo a 1-week screening period to eligibility for study entry.At week 0,patients who meet the eligibility requirements will be randomized into two groups(experimental group and control group)in a 1:1 ratio to Tangningtongluo tablets(4 tablets,tid,po.) or Calcium dobesilate capsules(1 capsule,tid,po.).
Interventions
DRUGTangningtongluo tablets
Four pills each time and three times a day after meals.
1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.
Sponsors
Guizhou Bailing Group Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected vision acuity (BCVA) | At 24 weeks | using ETDRS vision chart measure vision change from Baseline |
| diabetic retinopathy(DR)progression rate | At 24 weeks | Using ETDRS Classification to evaluate DR Progress rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal macular optical coherence tomography angiography (OCTA) | At 12, 24weeks | measure macular vascular density, retinal thickness, retinal volume; |
| HbA1c | At 12,24,36 and 48 weeks | Measure the patient's HbA1c |
| Fundus photography | At 12, 24weeks | quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter. |
| Efficacy of traditional Chinese medicine syndrome. | At 12, 24 and 48 weeks | It includes the evaluation of the main symptoms such as blurred vision, dry eyes, secondary symptoms such as mental fatigue, shortness of breath and lazy speech, dry mouth and dry throat and etc. |
| Routine eye examination; | At 4,8,12, 24,36 and 48 weeks | Including the examination of cornea, lens, anterior chamber, iris, etc |
| Retinal blood oxygen saturation | At 12, 24weeks | measure retinal blood oxygen saturation |
Countries
China
Outcome results
None listed