Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy
- Conditions
- Type2 DiabetesDiabetic Retinopathy
- Interventions
- Drug: Tangningtongluo tablets
- Registration Number
- NCT05007262
- Lead Sponsor
- Guizhou Bailing Group Pharmaceutical Co Ltd
- 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.).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
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- Patients with the diagnosis of type 2 diabetes.
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- Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate.
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- Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1).
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- Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine.
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- HbA1C ≤ 9%.
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- Age between 18 and 75 years old
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- Informed consent, voluntary subject. The process of obtaining informed consent form complies with Good Clinical Practice(GCP).
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- Patient with the diagnosis of diabetic retinopathy is combined with severe vitreous blood effusion, or required total retinal laser treatment or vitrectomy.
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- Patient who has been treated with full retinal laser photocoagulation.
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- Patient with difficulty in evaluating fundus images with refractive medium turbidity.
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- Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month.
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- Patient with other serious diabetes complications, such as diabetes gangrene.
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- Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition.
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- Female patient with pregnancy, or prepare for pregnancy, or lactating.
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- Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases.
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- 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.
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- Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract.
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- Patient participated in other clinical researches within a month.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium dobesilate capsules Calcium dobesilate capsules Calcium dobesilate capsules, 1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.After 24 weeks, the researchers will decide whether to continue depend on the patient condition and willingness. The maximum medication time is up to 48 weeks.Basic treatment: According to the comprehensive objectives of China Type 2 Diabetes Guidelines (2020 Edition) .The Angiotensin-Converting Enzyme（ACEI ）and Angiotensin Receptor Blocker （ARB） drugs will be continued to use as the original treatment protocol. Tangningtongluo tablets Tangningtongluo tablets Tangningtongluo tablets, 4 tablets one time,tid,po, taken after meals.The patients will receive drugs for 24 weeks continuously. After 24 weeks, the researchers will decide whether to continue depend on the patient condition and willingness. The maximum medication time is up to 48 weeks.Basic treatment: According to the comprehensive objectives of China Type 2 Diabetes Guidelines (2020 Edition) .The Angiotensin-Converting Enzyme（ACEI） and Angiotensin Receptor Blocker（ARB） drugs will be continued to use as the original treatment protocol.
- Primary Outcome Measures
Name Time Method diabetic retinopathy(DR)progression rate At 24 weeks Using ETDRS Classification to evaluate DR Progress rate
Best corrected vision acuity (BCVA) At 24 weeks using ETDRS vision chart measure vision change from Baseline
- Secondary Outcome Measures
Name Time Method Fundus photography At 12, 24weeks quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.
Retinal blood oxygen saturation At 12, 24weeks measure retinal blood oxygen saturation
HbA1c At 12,24,36 and 48 weeks Measure the patient's HbA1c
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.
Retinal macular optical coherence tomography angiography (OCTA) At 12, 24weeks measure macular vascular density, retinal thickness, retinal volume;
Routine eye examination; At 4,8,12, 24,36 and 48 weeks Including the examination of cornea, lens, anterior chamber, iris, etc
Trial Locations
- Locations (13)
Gansu Provincial Hospital of traditional Chinese Medicine
🇨🇳Lanzhou, Gansu, China
Chongqing hospital of traditional Chinese Medicine
🇨🇳Chongqing, Chongqing, China
People's Hospital of Anshun City Guizhou Province
🇨🇳Anshun, Guizhou, China
The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
🇨🇳Guiyang, Guizhou, China
The First Hospital of Hunan University of Chinese Medicine
🇨🇳Changsha, Hunan, China
Hebei Provincial Hospital of traditional Chinese Medicine
🇨🇳Shijiazhuang, Hebei, China
Inner Mongolia Hospital of traditional Chinese Medicine
🇨🇳Hohhot, Inner Mongolia, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangshu, China
Yangzhou Hospital of traditional Chinese Medicine
🇨🇳Yangzhou, Jiangshu, China
Ineye Hospital of Chendu University of TCM
🇨🇳Chengdu, Sichuan, China
Eye Hospital of WMU
🇨🇳Wenzhou, Zhejiang, China
Banan Hospital Affiliated to Chongqing Medical University
🇨🇳Chongqing, Sichuan, China
South Central Hospital of Yunnan Province
🇨🇳Honghe Prefecture, Yunnan, China