Effectiveness and Safety of Yiqitongluo Granule for Stroke

NCT ID: NCT02604654

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-29

Study Completion Date

2017-12-06

Brief Summary

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The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yiqitongluo group

Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.

Group Type EXPERIMENTAL

Yiqitongluo granule

Intervention Type DRUG

administered after dissolved

Interventions

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Yiqitongluo granule

administered after dissolved

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* mild and moderate ischemic stroke patient with 4-25 NIHSS score
* stable patients within 1 week to 3 months
* sign informed consent before study

Exclusion Criteria

* CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
* severe disturbance of consciousness
* dysphagia
* TIA
* hemorrhagic diathesis
* patient with malignant tumor whose expected lifetime is less than 3 months
* allergic constitution
* gestation period, lactation period, woman with the possibility or plan of pregnancy
* those who participated in other clinical trials within 3 months or taking part in other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shineway Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role collaborator

Yi Yang

OTHER

Sponsor Role lead

Responsible Party

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Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yi Yang

Role: STUDY_CHAIR

The First Hospital of Jilin University

Zhenni Guo

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Other Identifiers

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SWYY-YQTLKL

Identifier Type: -

Identifier Source: org_study_id

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