Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: yongjun wang

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.