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Effect of Compound Danshen Dropping Pills on non-proliferative diabetic retinopathy: A real-world Study

Effect of Compound Danshen Dropping Pills on non-proliferative diabetic retinopathy: A real-world Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068447
Enrollment
Unknown
Registered
2023-02-20
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Diabetic retinopathy

Interventions

routine treatment group:basic treatment + calcium dobesilate 0.5g three times a day
Compound Danshen Dropping Pills treatment group:basic treatment + Compound Danshen Dripping Pills 20 pills three times a day
compound treatment group:basic treatment + calcium dobesilate 0.5g three times a day + Compound Danshen Dripping Pills 20 pills three times a day

Sponsors

Nanjing Lishui People's Hospitial (Zhongda Hospital Lishui Branch, Southeast University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, male or female; 2. Diagnosis of diabetes (type 1 or type 2, using the World Health Organization diagnostic criteria for diabetes in 1999 and the classification criteria for glucose metabolism status); 3. Fundus photography based on mydriasis free artificial intelligence screening system for diabetes retinopathy, confirmed as NPDR (at least one eye was diagnosed as NPDR); 4. Volunteer to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to any component of Compound Danshen Dropping Pills and calcium dobesilate; 2. Pregnant or lactating women or women planning to become pregnant are unwilling or fail to take adequate contraceptive measures; 3. There are other reasons that cause retinal diseases, or there are other conditions such as cataract, glaucoma, which hinder retinal examination and high-quality photography; 4. Patients who have been treated with drugs to improve microcirculation within 2 weeks before the start of the study or who have used drugs whose efficacy is similar to any component of Compound Danshen Dropping Pill; 5. Those who have received anti-VEGF treatment within 3 months before the start of the study; 6. Have participated or are participating in other clinical trials one month before screening; 7. Abnormal liver function: alanine aminotransferase (ALT) >= 2 times the upper limit of normal value (ULN), or alanine aminotransferase (AST) >= 2 times the ULN, or total bilirubin >= 1.5 times the ULN(except for those caused by mild fatty liver); 8. Severe renal insufficiency: GFR <= 30ml/min/1.73m^2.

Design outcomes

Primary

MeasureTime frame
ETDRS score;

Secondary

MeasureTime frame
vision;number of lesions of diabetes retinopathy;area of lesions of diabetes retinopathy;

Countries

China

Contacts

Public ContactBingquan Yang

Nanjing Lishui People's Hospitial (Zhongda Hospital Lishui Branch, Southeast University)

yangbingquan@seu.edu.cn+86 139 5173 9179

Outcome results

None listed

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