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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNTL Experimental Group | Active Comparator | TNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. |
|
| TNTL Control Group | Placebo Comparator | TNTL simulation preparation,oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNTL | Drug | oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | From enrollment to the end of treatment at 4 weeks,8weeks,12weeks,16weeks,20weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and reactions | Record adverse events, including number of participants with abnormal vital signs,urine analysis, urinalysis,liver function , etc | From enrollment to the end of treatment at 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinxin Clinical Project Manager | Contact | +86 13885383954 | trade@beletalent.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongsheng Bi | Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuancheng People's Hospital | Recruiting | Xuancheng | Anhui | 242000 | China |
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| TNTL simulation preparation |
| Drug |
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks. |
|
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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. | From enrollment to the end of treatment at 4,8,12,16,20, and 24 weeks |
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510405 | China |
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| Shenzhen Eye Hospital | Recruiting | Shenzhen | Guangdong | 518040 | China |
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| Zhuhai People's Hospital | Recruiting | Zhuhai | Guangdong | 519099 | China |
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| The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine | Recruiting | Guiyang | Guizhou | 550001 | China |
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| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | 550002 | China |
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| Shijiazhuang People's Hospital | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Kaifeng Central Hospital | Recruiting | Kaifeng | Henan | 475000 | China |
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| Luoyang Third People's Hospital | Recruiting | Luoyang | Henan | 471099 | China |
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| Xinxiang Central Hospital | Recruiting | Xinxiang | Henan | 453001 | China |
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| People's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | 450014 | China |
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| Zhengzhou Second Hospital | Recruiting | Zhengzhou | Henan | 450015 | China |
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| Taihe Hospital (Affiliated Hospital Of Hubei University Of Medicine) | Recruiting | Shiyan | Hubei | 442099 | China |
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| Wuhan Puren Hospital | Recruiting | Wuhan | Hubei | 430080 | China |
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| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | 443000 | China |
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| The First Affiliated Hospital Of University Of South China | Recruiting | Hengyang | Hunan | 421001 | China |
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| Wuxi People's Hospital | Recruiting | Wuxi | Jiangsu | 214023 | China |
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| Affiliated Zhongshan Hospital Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
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| Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital | Recruiting | Jinan | Shandong | 250011 | China |
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| Shandong University of Traditional Chinese Medicine Affiliated Hospital | Recruiting | Jinan | Shandong | 250012 | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
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| Shandong Second Provincial General Hospital | Recruiting | Jinan | Shandong | 250022 | China |
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| Liaocheng People's Hospital | Recruiting | Liaocheng | Shandong | 252000 | China |
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| The First People'S Hospitalof Xian Yang | Recruiting | Xianyang | Shanxi | 712000 | China |
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| Xian No.1 Hospital | Recruiting | Xi’an | Shanxi | 710002 | China |
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| The First Affiliated Hospital of Xi'an Medical University | Recruiting | Xi’an | Shanxi | 710077 | China |
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| The Affiliated Hospital of Southwest Medical University | Recruiting | Luzhou | Sichuang | 646099 | China |
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| Panzhihua Integrated Traditional Chinese and Western Medicine Hospital | Recruiting | Panzhihua | Sichuang | 617000 | China |
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| Yunnan University Affiliated Hospital | Recruiting | Kunming | Yunnan | 650021 | China |
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