Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke "HTZZP-INF"


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Patient must be between the ages of 18 and 70 years.
- Patient must be with ischemic stroke and at stroke onset 14th day.
- Patient must be with mRS score <5 at enrollment and mRS score ≤1 before stroke onset.
- Symptoms and imaging of CT (computed tomography) or MRI (Magnetic Resonance Imaging) support the diagnosis of ischemic stroke.
- Patient must be with 4 ≤ NIHSS ≤16.
- Patient must be with Glasgow coma scale (GCS) ≥7.
- Only patient with an anterior circulation infarction of Oxfordshire Community Stroke Project (OCSP)classification and atherothrombosis or cardioembolism of modified TOAST classification were accepted.
- Patient must understand and be willing, able and likely to comply with all study requirements.
- Informed consent must be obtained.

Exclusion Criteria

- Patient with severe cognitive impairment who not be able to give voluntary written informed consent or participate in this study.
- Maybe not to comply with all study requirements or not be able to participate in this study for regional or social reasons.
- Pregnancy, breast feeding and the possible pregnancy during study.
- Participating in another medicine or interference study in the same time or at least within 3 months, or enrolled in this study in other location.
- Patient with mRS≥5 at enrollment.
- Coma patient with GCS<7.
- Patient with severe cerebral function impairment which was not caused by stroke.
- Patient with dysphagia, Wyatt score ≥2.
- Lacunar infarction.
- Patient accompanied with systemic diseases: gastrointestinal hemorrhage, advanced carcinoma, liver malfunction, kidney malfunction, severe dementia or mental disorder.
- Unstable patient after receiving thrombolytic therapy.
- Cerebral hemorrhage verified by CT or MRI.
- History of major operation or trauma within 6 weeks or having a major operation arrangement.
- Allergic to one or more components of study medicine.
- Receiving study medicine or components of study medicine within 2 weeks.