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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Huashan Hospital
Sponsor:
Collaborator:
Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd
Information provided by (Responsible Party):
Qiang Dong, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01758536
First received: December 24, 2012
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Drug: Huatuo Zaizao Pills
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IV, Double Blind, Placebo-controlled, Randomized, Multi-Center Study to Evaluate the Efficacy of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke

Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • modified Rankin Scale [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The primary end point is the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months.


Secondary Outcome Measures:
  • modified Rankin Scale,NIHSS, Barthel Index, and MMSE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    • The proportion of patients with a modified Rankin Scale (mRS) score of 0 to 2 at 3 months.
    • NIHSS (National Institute of Health Stroke Scale) score.
    • The proportion of patients with BI no less than 75 at 3 months.
    • MMSE(Mini-Mental State Examination)score.


Other Outcome Measures:
  • Traditional Chinese Symptoms and tongue image [ Time Frame: the first day of enrollment ] [ Designated as safety issue: Yes ]
    Recording the Traditional Chinese Symptoms and taking tongue photo for traditional Chinese doctors to perform subgroup analysis


Estimated Enrollment: 1100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Pills
  • 12 g each time, twice daily.
  • 3 months
Drug: Huatuo Zaizao Pills
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.
Other Name: Huatuo Zaizao Wan
Experimental: Huatuo Zaizao Pills
  • 12 g each time, twice daily.
  • 3 months.
Drug: Huatuo Zaizao Pills
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.
Other Name: Huatuo Zaizao Wan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758536

Contacts
Contact: Zheng-yu Lu, MD 8613817912099 luzhengyu@yahoo.cn

Locations
China
Shanghai Shuguang Hospital Active, not recruiting
Shanghai, China, 201203
Shanghai Tenth People's Hospital Active, not recruiting
Shanghai, China, 200072
Shanghai First People's Hospital Active, not recruiting
Shanghai, China, 200081
Huashan Hospital Recruiting
Shanghai, China, 200040
Contact: Zheng-yu Lu    021-52887145    luzhengyu@yahoo.cn   
Contact: Xiang Han    021-52887145    hansletter@163.com   
Sponsors and Collaborators
Huashan Hospital
Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd
Investigators
Principal Investigator: Qiang Dong, MD Huashan Hospital
  More Information

No publications provided

Responsible Party: Qiang Dong, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01758536     History of Changes
Other Study ID Numbers: QIXING-2012
Study First Received: December 24, 2012
Last Updated: January 18, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Huashan Hospital:
ischemic stroke
neural function
life quality

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014