Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Huatuo Zaizao Pills is a pure natural preparation from plant origin and consists of Chuanxiong rhizome, Evodia fruit and etc. Most of its ingredients are not opened and reserved by the National Commission for Science and Technology and the State Food and Drug Administration.

Huatuo Zaizao Pills was approved for marketing as a drug over several decades for treating and preventing cardiovascular and cerebrovascular diseases and their sequela. It is used to symptoms induced by blood stasis or stagnation of phlegm-wetness, such as stroke and paralysis, stiffness and numbness, deviation of the eye and mouth and dysphasia.

Based on the history of Huatuo Zaizao Pills for the treatment of cerebral infarction and hemorrhagic stroke, investigators will perform a phase IV, double blind, placebo-controlled, randomized and multi-Center clinical trial in China to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.

The study was designed with a target sample size of 1100 patients and the investigators will perform 200 patients in the first period. Patients will be randomly assigned to receive Huatuo Zaizao Pills or placebo at dose of 12g each time, twice daily.

The investigators hypothesis that this study might offer based medicine evidence to test and verified the efficacy of Huatuo Zaizao Pills in improving the neural function and life quality in patients with ischemic stroke. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01758536
Study type	Interventional
Source	Huashan Hospital
Contact	Zheng-yu Lu, MD
Phone	8613817912099
Email	luzhengyu@yahoo.cn
Status	Recruiting
Phase	Phase 4
Start date	December 2012
Completion date	December 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms