Retinal and corneal neuroprotective effects of qiming granules or calcium dobesilate in patients with non-proliferative diabetic retinopathy

Not Applicable

Completed

• Conditions: on-proliferative diabetic retinopathy; Eye Diseases

• Registration Number: ISRCTN94680105
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-31
• Study Start: 2023-03-04
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Aged 18-70 years old (including boundary value)
2. Patients diagnosed with Type 2 diabetes(according to 1999 WHO criterion)
3. Patients with non-proliferative diabetic retinopathy (NPDR) (According to fundus photography and International Clinical Classification Standard for diabetes Retinopathy (2002))
4. Subjects were treated with stable hypoglycemic drugs for at least 3 months
5. Subjects signed informed consent

Exclusion Criteria

1. Subjects with other non-diabetic eye diseases interfering with fundus examination results (such as glaucoma, cataract, non-diabetic hemorrhagic eye disease, uveitis, retinal detachment, optic nerve disease, refractive stromal abnormalities, etc.)
2. Subjects with proliferative retinopathy (PDR)
3. glycosylated hemoglobin (HbA1C)>8.0%
4. Subjects with diabetic retinopathy caused by type 1 and special types of diabetes
5. Subjects who underwent eye surgery or treatment within 6 months
6. Subjects with central nervous system diseases
7. Subjects suffering from allergic diseases or allergic to this medicine
8. Subjects participated in other drugs trials within 3 months
9. Subjects were treated with drugs for diabetic retinopathy
10. Uncontrolled hypertension or untreated hypertension(defined as systolic blood pressure(SBP)>160mmHg or diastolic blood pressure(DBP)>100mmHg during screening)
11. Severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, genitourinary system diseases, etc.), malignant tumors, mental diseases and other diseases that may interfere with the results of this study
12. Impaired liver function, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level = 2.5 times the upper limit of normal value
13. Renal insufficiency (eGFR<45ml/min)
14. Women who are pregnant, breastfeeding or preparing for pregnancy
15. Subjects suffering from cancer requiring treatment in the past five years or expected to die within five years
16. Unwilling to sign informed consent
17. Subjects who cannot take medication as planned, and those who are unwilling or unable to accept regular visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified