A randomized, Controlled, Multicenter Clinical Study Comparing the Efficacy and Safety of Saubude-9 pills in the treatment of Sa disease (cerebral infarction)

Phase 1

• Conditions: Cerebral infarction recovery period; I69.300×003

• Registration Number: ITMCTR2200006153
• Lead Sponsor: Inner Mongolia International Mongolian Medical Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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;
?Those with other diseases that affect the function of limb movement and those with limb movement dysfunction caused by osteoarthritis, rheumatoid arthritis, gouty arthritis, etc., which may affect the nerve or function examination before treatment;
?Those who were unable to independently complete daily activities due to various diseases and constitutions before the disease had a severe impact on the efficacy evaluation;
?Women who are pregnant or planning to become pregnant or breastfeeding;
?Those who are known to be allergic to the ingredients of this drug or have a severe allergic constitution;
?Those who have participated in clinical trials of other drugs within 3 months;
?Those who have used drugs known to major damage organs within 4 weeks;
?dysphagia who cannot take medicine; patients who have undergone thrombolytic therapy;

Study & Design

• Study Type: Treatment study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the modified Rankin scale, Barthel index score, NIHSS score, Mongolian Medical Syndrome Scale, and safety indexes;