A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Tongluo Mingmu Capsules in the treatment of non-proliferative diabetic retinopathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600118638

Enrollment

Unknown

Registered

2026-02-09

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Proliferative Diabetic Retinopathy

Interventions

Control group: Tongluo Mingmu Capsule placebo:placebo

Experimental group: Tongluo Mingmu Capsule:Tongluo Mingmu Capsule

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-70 years (inclusive); 2.At least one eye diagnosed with non-proliferative diabetic retinopathy caused by type 2 diabetes; 3.Having received stable glycemic control treatment for at least 12 weeks; 4.The subject voluntarily signs the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Glycated hemoglobin (HbA1c) level > 8%; 2.Having previously received retinal laser photocoagulation treatment or being eligible for photocoagulation therapy; 3.Blood pressure remaining >160/100 mmHg despite regular use of antihypertensive medications; 4.Use of medications for diabetic retinopathy (DR) or microcirculation improvement within the past 12 weeks; 5.Presence of other ocular diseases, such as glaucoma, cataract, non-diabetic retinopathy, uveitis, retinal detachment, optic nerve disorders, or high myopia; 6.Impaired liver or kidney function meeting any of the following criteria: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), or alkaline phosphatase (ALP) > 2.0 × ULN; serum creatinine (Cr) > 2.0 × ULN; blood urea nitrogen (BUN)/urea (UREA) > 2.0 × ULN; 7.Abnormal lipid profile meeting any of the following criteria: total cholesterol > 2.0 × ULN, low-density lipoprotein cholesterol > 2.0 × ULN, triglycerides > 2.0 × ULN; 8.History of severe psychiatric or psychological disorders; 9.Pregnant women, those planning pregnancy, or lactating women; 10.Allergy to any component of the investigational drug; 11.Participation in other clinical trials within the past three months; 12.Investigator’s judgment that the subject has potential risks or other factors making them unsuitable for participation in this trial;

Design outcomes

Primary

Measure	Time frame
DRSS grade;	—

Countries

China

Contacts

Public ContactKuang Hongyyu

The First Affiliated Hospital of Harbin Medical University

ydykuanghongyu@126.com+86 451 8555 2350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026