Non-proliferative diabetic retinopathy
Conditions
Interventions
Trial Group:Compound Danshen Dropping Pills, oral, 20 pills (540 mg) per dose, three times daily, for a duration of 52 weeks.
Control Group:Placebo of Compound Danshen Dropping Pills, oral, 20 pills (540 mg) per dose, three times daily, for a duration of 52 weeks.
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years (inclusive), gender unrestricted; 2. Meeting the diagnostic criteria for moderate non-proliferative diabetic retinopathy (refer to the Clinical Guidelines of Ophthalmology): (1)Confirmed history of diabetes; (2)Clinical symptoms: blurred vision, visual distortion, or sudden vision loss, etc.; (3)Auxiliary examination: Direct ophthalmoscopy after mydriasis reveals: presence of microaneurysms but less severe than severe NPDR; no macular edema. (International diagnostic criteria for severe NPDR include any one of the following findings, in the absence of signs of proliferative retinopathy: more than 20 intraretinal hemorrhages in each of the four quadrants; definite venous beading in two or more quadrants; prominent intraretinal microvascular abnormalities (IRMA) in one or more quadrants.) 3. Meeting the diagnostic criteria for Qi stagnation and blood stasis syndrome in Traditional Chinese Medicine (refer to the Guiding Principles for Clinical Research of New Chinese Medicines): (1)Primary symptoms: stabbing pain, fixed pain, pain aggravated by pressure, stagnant blood in the collaterals (such as dark purple lips, gums, or nails, superficial red streaks on the skin, or visible abdominal veins), subcutaneous ecchymosis, masses, or extravasated blood; (2)Secondary symptoms: scaly dry skin, limb numbness or hemiplegia, dementia, mania, poor memory, localized paresthesia, history of trauma, surgery, or induced abortion; (3)Purple-dark tongue or tongue with ecchymosis or petechiae, and engorged sublingual veins; (4)Rough or absent pulse, deep-wiry pulse, or wiry-slow pulse. Diagnosis can be made with 2 primary symptoms + tongue and pulse findings, or 1 primary symptom + 2 secondary symptoms + tongue and pulse findings. 4. Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes mellitus. 2. Patients with persistent hyperglycemia where HbA1c > 10%. 3. Patients allergic to Chinese herbal components, or those who discontinued other treatments for diabetic retinopathy with Chinese herbs for less than 4 weeks. 4. Patients who have undergone photocoagulation for retinopathy, are suitable candidates for photocoagulation therapy, or have one or both eyes in the proliferative stage of diabetic retinopathy; patients with diabetic macular edema. 5. Patients with other ocular diseases (e.g., glaucoma, cataracts significantly affecting fundus examination, non-diabetic retinopathy, uveitis, retinal detachment, optic nerve diseases, or high myopia with fundus lesions). 6. Patients with severe primary diseases of the cardiovascular, hepatic, renal, or hematopoietic systems, or patients with mental illness. 7. Any other condition or treatment that makes the participant unsuitable for this study and prohibits involvement in the entire research period (e.g., active malignancy or other conditions expected to limit life expectancy to less than 12 months). 8. Pregnant women, those planning pregnancy, or breastfeeding women. 9. Participants who have enrolled in other drug clinical trials within the past three months. 10. Participants who have been using Aodisi or similar medications for more than three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients progressing to meet the indications for laser surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite endpoint events of diabetic retinopathy progression;The overall efficacy of comprehensive evaluation ;Retinopathy Severity Grading;Incidence of macular edema;Corrected Vision Status;Fundus Changes FFA Scale, FP Hemorrhage, FP Exudative Evaluation;Quality of Life Scale;The scoring changes of TCM syndromes;The date of the initial retinal laser therapy.; | — |
Countries
China
Contacts
Public ContactWang Bing
Shanghai Sixth People's Hospital
Outcome results
None listed