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.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
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.
Chongqing hospital of traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
Gansu Provincial Hospital of traditional Chinese Medicine
Lanzhou, Gansu, China
Best corrected vision acuity (BCVA)
using ETDRS vision chart measure vision change from Baseline
Time frame: At 24 weeks
diabetic retinopathy(DR)progression rate
Using ETDRS Classification to evaluate DR Progress rate
Time frame: At 24 weeks
Fundus photography
quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.
Time frame: At 12, 24weeks
Retinal blood oxygen saturation
measure retinal blood oxygen saturation
Time frame: At 12, 24weeks
Retinal macular optical coherence tomography angiography (OCTA)
measure macular vascular density, retinal thickness, retinal volume;
Time frame: At 12, 24weeks
HbA1c
Measure the patient's HbA1c
Time frame: At 12,24,36 and 48 weeks
Routine eye examination;
Including the examination of cornea, lens, anterior chamber, iris, etc
Time frame: 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.
Time frame: At 12, 24 and 48 weeks
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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
Hebei Provincial Hospital of traditional Chinese Medicine
Shijiazhuang, Hebei, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 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
...and 3 more locations