Suspended
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
What is being tested
Tangningtongluo tablets
+ Calcium dobesilate capsules
Drug
Who is being recruted
Cardiovascular Diseases+9
+ Diabetes Mellitus
+ Diabetic Angiopathies
From 18 to 75 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: August 2021
Summary
Principal SponsorGuizhou Bailing Group Pharmaceutical Co Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 31, 2021
Actual date on which the first participant was enrolled.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.).
Official TitleClinical 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
Principal SponsorGuizhou Bailing Group Pharmaceutical Co Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRetinal DiseasesVascular DiseasesGlucose Metabolism DisordersDiabetes Complications
Criteria
7 inclusion criteria required to participate
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.
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11 exclusion criteria prevent from participating
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTangningtongluo 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.
Group II
Active ComparatorCalcium 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Suspended
The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
Guiyang, ChinaOpen The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine in Google MapsSuspended
Hebei Provincial Hospital of traditional Chinese Medicine
Shijiazhuang, ChinaSuspended
The First Hospital of Hunan University of Chinese Medicine
Changsha, ChinaSuspended
Inner Mongolia Hospital of traditional Chinese Medicine
Hohhot, ChinaSuspended13 Study Centers