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Study on therapy of dynamic treatment combining TCM individually intervention with diabetic microangiopathy syndromes.

clinical research of disease symptom of TCM on complications of diabetic microangiopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007072
Enrollment
Unknown
Registered
2015-09-11
Start date
2015-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Microvascular Complications of Diabetes

Interventions

diabetic retinopathy patients with disease differentiation syndrome differentiation-based treatment:Basic therapy+Qiming granule+Chinese medical herbs based syndrome differentiation
diabetic retinopathy patients with stationary treatment:Basic therapy+Qiming granule
diabetic retinopathy combined with diabetic nephropathy patients with disease differentiation syndrome differentiation-based treatment:Basic therapy+Qiming granule+Chinese medical herbs based syndrome
diabetic retinopathy combined with diabetic nephropathy patients with stationary treatment:Basic therapy+Qiming granule
diabetic retinopathy combined with diabetic neuropathy patients with disease differentiation syndrome differentiation-based treatment:Basic therapy+Qiming granule+Chinese medical herbs based syndrome
diabetic retinopathy combined with diabetic neuropathy patients with stationary treatment:Basic therapy+Qiming granule
diabetic retinopathy combined with diabetic nephropathy diabetic neuropathy patients with disease differentiation syndrome differentiation-based treatment:Basic therapy+Qiming granule+Chinese medical
diabetic retinopathy combined with diabetic nephropathy diabetic neuropathy patients with stationary treatment:Basic therapy+Qiming granule

Sponsors

Chengdu University of Traditional Chinese Medicine
Lead Sponsor

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

MeasureTime frame
BCVA;TCM syndrome evaluation;TCSS;eGFR;retinal hemorrhage;retinal hard exudates;retinal soft exudation;VAS score change;

Secondary

MeasureTime frame
routine blood test;HbA1c;TBIL;ALT;AST;BUN;Crea;Fasting glucose;routine urine test;ECG;ACR;intraocular pressure;OCT;EMG;

Countries

China

Contacts

Public ContactJunguo Duan
duanjgs@126.com+86 13808048959

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 6, 2026