Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.

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

Details

• Lead Sponsor: Huashan Hospital
• Collaborator: Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd

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.