The goal of this clinical trial is to learn if drug TNTL works to treat non-proliferative diabetic retinopathy in adults. It will also learn about the safety of drug TNTL. The main questions it aims to answer are: 1. Does drug TNTL can improve visual acuity and reduce the degree of retinopathy? 2. What medical problems do participants have when taking drug TNTL? Researchers will compare drug TNTL to a placebo (a look-alike substance that contains no drug) to see if drug TNTL works to treat non-proliferative diabetic retinopathy. Participants will: 1. Take drug TNTL or a placebo every day for 6 months 2. Visit the clinic once every 4 weeks for checkups and tests 3. Keep a diary of their symptoms and Change from baseline
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
Xuancheng People's Hospital
Xuancheng, Anhui, China
RECRUITINGBeijing Chaoyang Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGShenzhen Eye Hospital
Shenzhen, Guangdong, China
Change in best corrected visual acuity (BCVA) from baseline after 24 weeks of medication;
After 24 weeks of medication, the subjects' best corrected visual acuity (BCVA) was checked and compared with the value measured at week 0 to observe the degree of change from baseline value;
Time frame: From enrollment to the end of treatment at 24 weeks
Change in best corrected visual acuity (BCVA) from baseline after medication
After 4 weeks,8weeks,12weeks,16weeks,20weeks of medication, the subjects' best corrected visual acuity (BCVA) was checked separately and compared with the value measured at week 0 to observe the degree of change from baseline value;
Time frame: From enrollment to the end of treatment at 4 weeks,8weeks,12weeks,16weeks,20weeks
The change and progression rate of ETDRS classification DR Classification from baseline after 12 and 24 weeks of medication;
After 12 weeks,24 weeks of medication, the subjects' ETDRS classification based on the Diabetic Retinopathy Severity Score and compared with the value measured at week 0 to observe the change and progression rate from baseline value as required, with a minimum score of 10 and a maximum score of 90. The higher the score, the more severe it is.
Time frame: From enrollment to the end of treatment at 12weeks and 24weeks.
The proportion of subjects whose best corrected visual acuity (BCVA)increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication;
After 4,8,12,16,20,24 weeks of medication, count the proportion of subjects whose best corrected visual acuity(BCVA) increased by ≥ 5, ≥ 10, ≥ 15 compared to baseline
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
The proportion of subjects whose best corrected visual acuity (BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline after medication
After 4,8,12,16,20,24 weeks of medication, count the proportion of subjects whose best corrected visual acuity(BCVA) decreased by ≥ 5, ≥ 10, ≥ 15 compared to baseline
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Changes in fundus condition compared to baseline
Changes in fundus condition compared to baseline after 12 and 24 weeks of medication
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in retinal macular optical coherence tomography (OCT) compared to baseline
Changes in retinal macular optical coherence tomography(OCT) after 12 and 24 weeks of medication compared to baseline
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in HemoglobinA1c compared to baseline
Changes in HemoglobinA1c levels compared to baseline after 12 and 24 weeks of medication
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in fasting blood glucose compared to baseline
Changes in fasting blood glucose levels after 4, 8, 12, 16, 20, and 24 weeks of medication compared to baseline
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
Effective rate of traditional Chinese medicine syndrome
After medication, use the Traditional Chinese Medicine Syndrome(yin deficiency with internal heat and blood stasis obstructing the collaterals of the eyes) Scale as required to score and calculate the effective rate,the lowest score is 0, the highest score is 30, and the higher the score, the more severe it is.
Time frame: From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks
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Zhuhai People's Hospital
Zhuhai, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou, China
RECRUITINGGuizhou Provincial People's Hospital
Guiyang, Guizhou, China
RECRUITINGShijiazhuang People's Hospital
Shijiazhuang, Hebei, China
RECRUITINGKaifeng Central Hospital
Kaifeng, Henan, China
RECRUITINGLuoyang Third People's Hospital
Luoyang, Henan, China
RECRUITING...and 20 more locations