Acute cerebral infarction complicated with diabetes mellitus
Conditions
Interventions
Control group.:Basic treatment: including but not limited to antiplatelet, hypoglycemic, brain protection, lipid lowering, symptomatic treatment (lowering blood pressure, regulating blood sugar, lower
Treatment group:Basic treatment + Fuyuan Xingnao decoction (Codonopsis pilosula 9g, Dannanxing 9g, Acorus tatarinowii 9g, Sanqi 3G, leech 3G, motherwort 27g, rhubarb 6g)
Sponsors
Shanghai traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) meet the diagnostic criteria of acute cerebral infarction in western medicine. 2) meet the diagnostic criteria of apoplexy (syndrome of wind-phlegm and blood stasis) in traditional Chinese medicine. 3) the course of the disease is within 2 weeks. 4) previously diagnosed as western medicine type 2 diabetes, glycosylated hemoglobin = 8% 5) the NIHSS score of clinical neurological impairment in ischemic stroke is 4-15 (including boundary value). 6) Age 18 and above, regardless of sex 7) those who had first onset or had a history of disease, but had no disability before this attack (improved Rankin scale scored 0: 1) 8) those with mRS score = 2 at the time of selection 9) volunteers who signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) patients with abnormal blood coagulation, cerebral hemorrhage, subarachnoid hemorrhage, bleeding tendency or severe hemorrhage within 3 months. 2) Cerebral embolism caused by brain tumor, brain trauma, brain parasitic disease, metabolic disorder, rheumatic heart disease and coronary heart disease confirmed by examination. 3) patients who were treated with endovascular therapy (such as thrombolysis, arterial thrombectomy, ultra-early thrombus aspiration and stenting) within 6 hours after the onset of the disease. 4) patients with TIA attack, cerebral hemorrhage, subarachnoid hemorrhage and asymptomatic cerebral infarction 5) patients who cannot be given orally. 6) patients with serious complications such as ketoacidosis and hyperosmotic coma 7) patients with antibiotics or probiotics / probiotics used within 1 month before enrollment 8) Oral anticoagulants (except aspirin enteric-coated tablets or clopidogrel hydrosulfate tablets) 9) patients with other diseases affecting limb activity, such as claudication, osteoarthritis (active), rheumatoid arthritis (active), gouty arthritis, etc., may affect nerves or functional examination. 10) those complicated with severe hypertension (systolic blood pressure = 160mmHg) or diabetes (blood glucose = 22.22mmo lstroke L), and the disease has not been controlled after treatment. 11) Digestive tract bleeding caused by active ulcers or other causes 12) in patients with severe heart and lung diseases and chronic liver and renal dysfunction, the ALT and AST of liver function damage were 1.5 times higher than the normal upper limit, the renal function damage BUN > 1.2 times of the normal upper limit, and the Cr > normal upper limit. 13) pregnant or lactating women 14) Persons with disabilities prescribed by law (blind, deaf, dumb, mentally retarded, mentally handicapped, physically disabled) 15) Drug or alcohol abusers 16) those who are known to be allergic to the ingredients of this drug 17) the researchers believe that there are any patients who are not suitable for selection or affect the participation or completion of the study. 18) patients who participated in other clinical studies within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with modified Rankin scale (mRS) score less than 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in neurological impairment (NIHSS score);The proportion of patients whose NIHSS score improved by 4 points (or more) or returned to 0: 1;Evaluation of the curative effect of TCM syndromes (excluding tongue and pulse);Changes of fasting blood glucose, fasting insulin, IL-6, TNF- a and CRP in patients;Incidence of MACCE;Incidence of stroke-related complications; | — |
Countries
China
Contacts
Public ContactLi Ling
Shanghai traditional Chinese Medicine Hospital
Outcome results
None listed