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

Recruiting

Phase 4 Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Huatuo Zaizao Pills Drug
    Other Names: Huatuo Zaizao Wan
    Intervention Desc: A tens of herbs botanical drug product 12 gram (g) in 72 mini pills formulation. It is to be used as 12 g each time, twice daily.
    ARM 1: Kind: Experimental
    Label: Placebo Pills
    Description: 12 g each time, twice daily. 3 months
    ARM 2: Kind: Experimental
    Label: Huatuo Zaizao Pills
    Description: 12 g each time, twice daily. 3 months.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale 3 months Yes
Secondary modified Rankin Scale,NIHSS, Barthel Index, and MMSE 3 months Yes

Sponsors