ITMCTR2200006153
Not yet recruiting
Phase 1
A randomized, Controlled, Multicenter Clinical Study Comparing the Efficacy and Safety of Saubude-9 pills in the treatment of Sa disease (cerebral infarction)
Inner Mongolia International Mongolian Medical Hospital0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cerebral infarction recovery period
- Sponsor
- Inner Mongolia International Mongolian Medical Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Meet the diagnostic criteria of Western medicine for cerebral infarction in the convalescent period;
- •? The disease was in line with the diagnostic criteria for anterior circulation cerebral infarction;
- •? Meet the diagnostic criteria of Mongolian medical Sa disease;
- •? The course of the disease: 15 to 45 days from the date of onset;
- •? The first onset, or those with a history of cerebral infarction but no disability before this onset (modified Rankin scale score \=1 point);
- •? Using the National Institutes of Health Observatory Stroke Scale (NIHSS) scoring standard, the score of neurological deficit was \=7 points and \=22 points;
- •? Age \=40 years old, \=75 years old;
- •? Volunteer subjects and signed informed consent.
Exclusion Criteria
- •?Posterior circulation cerebral infarction, lacunar infarction, transient ischemic attack (TIA);
- •?Those who have suffered from cerebrovascular disease in the past and have severe motor dysfunction;
- •?Complications affecting drug evaluation, including depression after stroke, dementia, cerebral haemorrhage after cerebral infarction, etc.;
- •?Stroke patients confirmed by examination to be caused by a brain tumour, brain trauma, blood disease, etc.;
- •?Patients with cerebral embolism due to rheumatic heart disease, coronary heart disease and other heart disease combined with atrial fibrillation;
- •?Combined with severe disorders such as liver, kidney, hematopoietic system, endocrine system, osteoarthropathy, mental illness, ALT, AST \= 2 times the upper limit of normal, Cr \> upper limit of normal;
- •?Those with a tendency to bleed or those with severe bleeding within 12 weeks;
- •?Combined with severe hypertension or diabetes and other diseases, those who cannot control the disease after treatment;
- •?Lack of clear diagnostic evidence such as imaging or insufficient imaging diagnostic evidence to determine the diagnosis;
- •?Severe illness or coma affects the evaluation of curative effect;
Outcomes
Primary Outcomes
Not specified
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