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Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy
Sponsor: Beletalent (Zhuhai) Pharmaceutical Co., Ltd
Summary
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
Official title: Phase III Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy(With Syndrome of Yin Deficiency With Internal Heat and Blood Stasis Obstructing the Collaterals of the Eyes)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-04-29
Completion Date
2026-12-31
Last Updated
2025-08-24
Healthy Volunteers
No
Conditions
Interventions
TNTL
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
TNTL simulation preparation
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
Locations (30)
Xuancheng People's Hospital
Xuancheng, Anhui, China
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Shenzhen Eye Hospital
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Luoyang Third People's Hospital
Luoyang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Zhengzhou Second Hospital
Zhengzhou, Henan, China
Taihe Hospital (Affiliated Hospital Of Hubei University Of Medicine)
Shiyan, Hubei, China
Wuhan Puren Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, China
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
Jinan, Shandong, China
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Second Provincial General Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The First People'S Hospitalof Xian Yang
Xianyang, Shanxi, China
Xian No.1 Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuang, China
Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
Panzhihua, Sichuang, China
Yunnan University Affiliated Hospital
Kunming, Yunnan, China