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)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age range of 18 to 75 years old (including boundary values);
• Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetes retinopathy is classified as NPDR and mild and moderate patients;
• Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34 points (ETDRS visual acuity chart, visual acuity equivalent to a score of 20/200, decimal 0.1);
• Patients who meet the syndrome differentiation criteria of Yin deficiency, internal heat, and eye meridian stasis in traditional Chinese medicine;
• During the screening period, glycated hemoglobin (HbA1c) should be ≤ 8.5%;
• Agree to participate in this clinical study and voluntarily sign the informed consent form.
Locations
Other Locations
China
Beijing Chaoyang Hospital
RECRUITING
Beijing
Affiliated Zhongshan Hospital Dalian University
RECRUITING
Dalian
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
RECRUITING
Guangzhou
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
RECRUITING
Guiyang
The First Affiliated Hospital Of University Of South China
RECRUITING
Hengyang
Shandong Provincial Hospital
RECRUITING
Jinan
Shandong Second Provincial General Hospital
RECRUITING
Jinan
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
RECRUITING
Jinan
Shandong University of Traditional Chinese Medicine Affiliated Hospital
RECRUITING
Jinan
Kaifeng Central Hospital
RECRUITING
Kaifeng
Yunnan University Affiliated Hospital
RECRUITING
Kunming
Liaocheng People's Hospital
RECRUITING
Liaocheng
Luoyang Third People's Hospital
RECRUITING
Luoyang
The Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
RECRUITING
Panzhihua
Shenzhen Eye Hospital
RECRUITING
Shenzhen
Shijiazhuang People's Hospital
RECRUITING
Shijiazhuang
Taihe Hospital （Affiliated Hospital Of Hubei University Of Medicine）
RECRUITING
Shiyan
Wuhan Puren Hospital
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
The First Affiliated Hospital of Xi'an Medical University
RECRUITING
Xi’an
Xian No.1 Hospital
RECRUITING
Xi’an
The First People'S Hospitalof Xian Yang
RECRUITING
Xianyang
Xinxiang Central Hospital
RECRUITING
Xinxiang
Xuancheng People's Hospital
RECRUITING
Xuancheng
Yichang Central People's Hospital
RECRUITING
Yichang
People's Hospital of Zhengzhou
RECRUITING
Zhengzhou
Zhengzhou Second Hospital
RECRUITING
Zhengzhou
Zhuhai People's Hospital
RECRUITING
Zhuhai
Contact Information
Primary
Jinxin Clinical Project Manager
trade@beletalent.com
+86 13885383954
Time Frame
Start Date:2025-04-29
Estimated Completion Date:2026-12-31
Participants
Target number of participants:360
Treatments
Active_comparator: TNTL Experimental Group
TNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
Placebo_comparator: TNTL Control Group
TNTL simulation preparation，oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.