Status:
COMPLETED
Tongxinluo Capsule in Ischemic Stroke Patients（TISS)
Lead Sponsor:
yongjun wang
Conditions:
Ischemic Stroke
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the effects in improving life self-care ability of stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos for 90 days.
Detailed Description
The study is a randomized, double-blind, placebo controlled, multi-center trial. We aim to enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less than 72 hours aft...
Eligibility Criteria
Inclusion
- Ischemic stoke within 72 after onset, confirmed by MRI or CT.
- Age 35-75 years, inclusive.
- Patients with the first attack or patients with stroke history(modified Rankin Scale score 0-1).
- Clear signs of localization of nervous system, NIHSS score 4 to 22.
- Patient or proxy has signed informed consent.
Exclusion
- Hemorrhage diseases according to head CT or MRI, such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, haemorrhage after cerebral infarction.
- Transient Ischemic Attack (TIA).
- Severe disturbance of consciousness: 1a of NIHSS score\>1 point; Difficulty in swallowing, unable to take oral capsules; any of 5a, 5b, 6a, 6b of NIHSS score\>2 point.
- Convinced of stroke caused by brain tumor, brain trauma, hemopathy, etc.
- Hemorrhagic tendency patients.
- Patients with endovascular treatment after the onset of stroke.
- Patients with dementia, severe Parkinson's disease, mental disorders, limb dysfunction caused by other diseases or other conditions that may affect the therapeutic efficacy.
- Uncontrolled hypertension (≥200 mmHg systolic or ≥110 mmHg diastolic) or hypotension (≤90 mmHg systolic or ≤60mmHg diastolic); severe hyperglycemia(blood glucose ≥400 mg/dl) or hypoglycemia( blood glucose≤50 mg/dl).
- Severe hepatic insufficiency defined as transaminase values \> 2x upper limit of normal; severe renal insufficiency defined as values serum creatinine\> 1.5x upper limit of normal; cardiac dysfunction or other serious systemic disease with life expectancy ≤3 months.
- Patients with concurrent malignancy or ongoing anti-tumor therapy.
- Patients with history of being allergic to the trial medicine.
- Pregnancy, breastfeeding or potential pregnancy.
- Within three months or currently participating in another investigational study.
- Any other condition that in the opinion of the investigator should preclude study participation.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
2007 Patients enrolled
Trial Details
Trial ID
NCT01919671
Start Date
March 1 2014
End Date
November 1 2016
Last Update
January 4 2017
Active Locations (1)
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1
Beijing TianTan Hospital,Capital Medical University
Beijing, China