Microvascular Complications of Diabetes
Conditions
Interventions
Gold Standard:
Index test:
Sponsors
Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients of type 2 diabetes; 2. Conform to qi yin deficiency channels stasis syndrome; 3. Patients diagnosed with diabetic retinopathy, or it with combined diabetic nephropathy, or it with combined diabetic distal, symmetric, mutiple neuropathy; 4. Objective eyes best corrected visual acuity (BCVA) >=34 scores (ETDRS visual chart, equivalent to Snellen 20/200, decimals 0.1); 5. HbA1C=6 scores or VAS >=4 scores; Note: Patients with combined DKD must also conform to one of the following two conditions: 1. GFR 15 to 60; 2. 300mg/g(> 30mg/mmol) >ACR>=30mg/g(3mg/mmol).
Exclusion criteria
Exclusion criteria: 1. Subjects with turbid dioptricmedia that can hardly conduct the eye fundus image evaluation; 2. Patients with spleen-stomach weakness yang deficiency, such as significant lerance of cold, long-term diarrhea dyspepsia etc; 3. The examination confirmed that the nephropathy is caused by the primary hypertension or other temic disease; 4. The non-diabetic neuropathies such as cervical & lumbar spondylopathy (radiculopathy, spinal canal stenosis, cervical & lumbar retrogression), cerebral infarction, Guillain-Barre syndrome, serious arteriovenous vascular disease (venous embolism, lymphangitis) etc; 5. Diabetes mellitus combined with lower limbs rupture; 6. The fundus high-risk PDR patients shall conduct the panrentinal photocoagulation immediately; 7. The kidney failure patients shall conduct the dialysis immediately; 8. Subjects who are allergic to the known ingredient of trail drug or the allergic constitution; 9. Combined serious heart disease (chronic heart failure, New York heart function over III, severe ventricular arrhythmias), abnormal liver function (AST, ALT >=twiceper normal limit) as well as severe disease such as hemopoietic tem, psychopath; 10. Patients with serious oculopathy including combined glaucoma, uveitis, age-related macular degeneration optic neuropathy etc; 11. Pregnancy or breast feeding women; 12. Patients with urologic diseases including combined glomerulonephritis, primary nephrotic syndrome, urinary tract infection, obstruction etc; 13. Patients with combined serious infection, diabetic ketoacidosis hyperkalemia; 14. Subjects that had participated in other clinic trails within three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA;TCM syndrome evaluation;retinal hemorrhage;retinal hard exudates;retinal soft exudation; | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT;EMG;TCSS;ACR;intraocular pressure; | — |
Countries
China
Contacts
Public ContactJunguo Duan
Outcome results
None listed