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

ITMCTR

Registry ID

ITMCTR2025001924

Enrollment

Unknown

Registered

2025-10-15

Start date

2025-10-25

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

NPDR

Interventions

Experimental Group:Tongluo Mingmu Capsules

Placebo group:Tongluo Mingmu Capsules Simulator

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) Stable antidiabetic treatment for at least 12 consecutive weeks; 4) The subject voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1) HbA1c >8%; 2) Those who have undergone or are eligible for panretinal photocoagulation therapy; 3) Individuals whose blood pressure remains >160/100 mmHg despite regular antihypertensive medication; 4) Use of drugs for treating DR (diabetic retinopathy) or improving microcirculation within the past 12 weeks; 5) Presence of other ocular diseases, such as glaucoma, cataracts, non-diabetic retinopathy, uveitis, retinal detachment, optic nerve diseases, or high myopia; 6) Liver or kidney dysfunction meeting one of the following criteria: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and alkaline phosphatase (ALP) >2.0×ULN; serum creatinine (Cr), blood urea nitrogen (BUN)/urea (UREA) >2.0×ULN; 7) Lipid profile meeting one of the following criteria: total cholesterol >2.0×ULN, low-density lipoprotein cholesterol >2.0×ULN, triglycerides >2.0×ULN; 8) Individuals with severe mental or psychological disorders; 9) Pregnant women, those planning pregnancy, or breastfeeding women; 10) Those allergic to any component of the investigational drug; 11) Participation in other clinical trials within the past three months; 12) Individuals deemed by the investigator to have potential risks or other factors making them unsuitable for this trial.

Design outcomes

Primary

Measure	Time frame
The proportion of DRSS score improvement =2 levels.;	—

Secondary

Measure	Time frame
Retinal microaneurysms, retinal hemorrhages, exudates, and improvement in intraocular pressure.;OCTA Parameters;HbA1c;NEI-VFQ-25 Score;C-peptide;Fasting blood glucose; 25-hydroxyvitamin D;Vision;blood lipids;	—

Countries

China

Contacts

Public ContactKuang Hongyu

THE FIRST AFFILIATED HOSPITAL OF HARBIN MEDICAL UNIVERSITY

khyhydfy@126.com13643381621

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026