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

Primary Purpose

Ischemic Stroke

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Huatuo Zaizao Pills

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, neural function, life quality

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Huashan HospitalRecruiting
Shanghai Tenth People's Hospital
Shanghai First People's Hospital
Shanghai Shuguang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Pills

Huatuo Zaizao Pills

Arm Description

12 g each time, twice daily. 3 months

12 g each time, twice daily. 3 months.

Outcomes

Primary Outcome Measures

modified Rankin Scale

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

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.

Full Information

NCT ID

NCT01758536

First Posted

December 24, 2012

Last Updated

January 18, 2013

Sponsor

Huashan Hospital

Collaborators

Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01758536

Brief Title

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

Acronym

HTZZP-INF

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

Collaborators

Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

ischemic stroke, neural function, life quality

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Pills

Arm Type

Placebo Comparator

Arm Description

12 g each time, twice daily. 3 months

Arm Title

Huatuo Zaizao Pills

Arm Type

Experimental

Arm Description

12 g each time, twice daily. 3 months.

Intervention Type

Drug

Intervention Name(s)

Huatuo Zaizao Pills

Other Intervention Name(s)

Huatuo Zaizao Wan

Intervention Description

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.

Primary Outcome Measure Information:

Title

modified Rankin Scale

Description

The primary end point is the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

modified Rankin Scale,NIHSS, Barthel Index, and MMSE

Description

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Traditional Chinese Symptoms and tongue image

Description

Recording the Traditional Chinese Symptoms and taking tongue photo for traditional Chinese doctors to perform subgroup analysis

Time Frame

the first day of enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zheng-yu Lu, MD

Phone

8613817912099

luzhengyu@yahoo.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiang Dong, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huashan Hospital

City

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zheng-yu Lu

Phone

021-52887145

luzhengyu@yahoo.cn

First Name & Middle Initial & Last Name & Degree

Xiang Han

Phone

021-52887145

hansletter@163.com

Facility Name

Shanghai Tenth People's Hospital

City

Shanghai

ZIP/Postal Code

200072

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Shanghai First People's Hospital

City

Shanghai

ZIP/Postal Code

200081

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Shanghai Shuguang Hospital

City

Shanghai

ZIP/Postal Code

201203

Country

China

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

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

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