Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy
NCT ID: NCT06817265
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2025-04-29
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy
NCT05007262
Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy
NCT03025399
Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR
NCT01759121
A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
NCT03258242
Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy
NCT02388984
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TNTL Experimental Group
TNTL, oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
TNTL
oral, 4 tablets, 3 times a day, after meals. Take it for 24 weeks.
TNTL Control Group
TNTL simulation preparation，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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Patients with macular edema who require anti Vascular Endothelial Growth Factor(VEGF) treatment;
* People with other eye diseases, such as retinal artery or vein occlusion, non diabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus examination, optic neuropathy and high myopia with fundus changes;
* Patients with acute complications of diabetes (such as diabetes ketoacidosis, hyperglycemia hyperosmolality syndrome, diabetes lactic acidosis, etc.) within one year before the screening period;
* People with other eye related complications of diabetes, such as iris neovascularization, angle neovascularization, and retinal neovascularization;
* acupuncture and moxibustion and other external treatment methods of traditional Chinese medicine were used to treat diabetes retinopathy within one week before enrollment;
* Patients who have used drugs clearly stated in the instruction manual to treat diabetes retinopathy, such as calcium dobesilate, pancreatic kallidinogenase, Qiming Granules, Shuangdan Mingmu Capsules, Compound Danshen Dropping Pills, Tongluo Mingmu Capsules, etc. within 2 weeks before enrollment;
* Patients who have undergone glaucoma, vitreous, retinal and other intraocular surgeries and procedures in the target eye within 3 months before enrollment;
* Patients who have undergone cataract surgery in the target eye within 3 months prior to enrollment and have not yet stabilized according to the researcher's assessment;
* Patients who have received intravitreal injections of anti VEGF antibodies and glucocorticoids in the target eye within 3 months prior to enrollment;
* Patients who have undergone total retinal laser photocoagulation treatment in the target eye;
* For those whose refractive media is turbid and difficult to evaluate fundus images in the target eye;
* Uncontrolled or controlled blood pressure with systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg;
* When screening, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) should be ≥ 1.5 times the upper limit of normal value;
* Patients with serious kidney disease (such as azotemia and uremia), diabetes foot, etc;
* When screening, individuals with severe primary diseases such as respiratory, cardiovascular, cerebrovascular, endocrine, digestive, and hematopoietic systems, or those with severe mental illnesses should be included;
* Suspected or confirmed history of alcohol or drug abuse;
* Pregnant women, lactating women, or women of childbearing age who are preparing to conceive; Female subjects of childbearing age or male subjects (with partners of childbearing age) who do not agree to voluntarily take effective contraceptive measures within one month after the last dose during the screening period;
* Individuals who are allergic to the drugs or their components used in this experiment;
* Participants who have participated in other clinical trials within the past month;
* The researchers believe that participants should not participate in the clinical trial.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beletalent (Zhuhai) Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hongsheng Bi
Role: PRINCIPAL_INVESTIGATOR
Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TNTL-DR-20241112
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.