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RECRUITING
NCT06817265
PHASE3

Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy

Sponsor: Beletalent (Zhuhai) Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

TNTL

oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.

DRUG

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