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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.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tangningtongluo tablets | Experimental | 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. |
|
| Calcium dobesilate capsules | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tangningtongluo tablets | Drug | Four pills each time and three times a day after meals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected vision acuity (BCVA) | using ETDRS vision chart measure vision change from Baseline | At 24 weeks |
| diabetic retinopathy(DR)progression rate | Using ETDRS Classification to evaluate DR Progress rate | At 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fundus photography | quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter. | At 12, 24weeks |
| Retinal blood oxygen saturation | measure retinal blood oxygen saturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junguo Duan, professor | Ineye Hospital of Chendu University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing hospital of traditional Chinese Medicine | Chongqing | Chongqing Municipality | 400011 | China | ||
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| Calcium dobesilate capsules | Drug | 1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach. |
|
| At 12, 24weeks |
| Retinal macular optical coherence tomography angiography (OCTA) | measure macular vascular density, retinal thickness, retinal volume; | At 12, 24weeks |
| HbA1c | Measure the patient's HbA1c | At 12,24,36 and 48 weeks |
| Routine eye examination; | Including the examination of cornea, lens, anterior chamber, iris, etc | At 4,8,12, 24,36 and 48 weeks |
| Efficacy of traditional Chinese medicine syndrome. | 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. | At 12, 24 and 48 weeks |
| Gansu Provincial Hospital of traditional Chinese Medicine |
| Lanzhou |
| Gansu |
| 730050 |
| China |
| People's Hospital of Anshun City Guizhou Province | Anshun | Guizhou | 561099 | China |
| The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine | Guiyang | Guizhou | 550003 | China |
| Hebei Provincial Hospital of traditional Chinese Medicine | Shijiazhuang | Hebei | 050013 | China |
| The First Hospital of Hunan University of Chinese Medicine | Changsha | Hunan | 410021 | China |
| Inner Mongolia Hospital of traditional Chinese Medicine | Hohhot | Inner Mongolia | 750306 | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangshu | 226006 | China |
| Yangzhou Hospital of traditional Chinese Medicine | Yangzhou | Jiangshu | 225012 | China |
| Ineye Hospital of Chendu University of TCM | Chengdu | Sichuan | China |
| Banan Hospital Affiliated to Chongqing Medical University | Chongqing | Sichuan | China |
| South Central Hospital of Yunnan Province | Honghe Prefecture | Yunnan | China |
| Eye Hospital of WMU | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003920 | Diabetes Mellitus |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000599174 | tangningtongluo |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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