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Effectiveness and Safety of Yiqitongluo Granule for Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Yiqitongluo granule
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Yiqitongluo group

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Safety of Yiqitongluo for stroke measured by laboratory index

    Secondary Outcome Measures

    Effect of Yiqitongluo for stroke with mRS
    mRS: modified Rankin Scale
    Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine
    Effect of Yiqitongluo for stroke with NIHSS
    NIHSS: the NIH stroke scale
    Effect of Yiqitongluo for stroke with BI
    BI: Barthel Index
    Effect of Yiqitongluo for stroke with EQ-5D
    The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

    Full Information

    First Posted
    November 11, 2015
    Last Updated
    August 19, 2021
    Sponsor
    Yi Yang
    Collaborators
    Shineway Pharmaceutical Co.,Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02604654
    Brief Title
    Effectiveness and Safety of Yiqitongluo Granule for Stroke
    Official Title
    Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 29, 2015 (Actual)
    Primary Completion Date
    November 5, 2017 (Actual)
    Study Completion Date
    December 6, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yi Yang
    Collaborators
    Shineway Pharmaceutical Co.,Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2197 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yiqitongluo group
    Arm Type
    Experimental
    Arm Description
    Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Yiqitongluo granule
    Intervention Description
    administered after dissolved
    Primary Outcome Measure Information:
    Title
    Safety of Yiqitongluo for stroke measured by laboratory index
    Time Frame
    change from baseline laboratory index at 28(±7) days
    Secondary Outcome Measure Information:
    Title
    Effect of Yiqitongluo for stroke with mRS
    Description
    mRS: modified Rankin Scale
    Time Frame
    90(±7) days
    Title
    Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine
    Time Frame
    28(±7) days
    Title
    Effect of Yiqitongluo for stroke with NIHSS
    Description
    NIHSS: the NIH stroke scale
    Time Frame
    28(±7) days
    Title
    Effect of Yiqitongluo for stroke with BI
    Description
    BI: Barthel Index
    Time Frame
    28(±7) days
    Title
    Effect of Yiqitongluo for stroke with EQ-5D
    Description
    The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
    Time Frame
    28(±7) days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi Yang
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Zhenni Guo
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness and Safety of Yiqitongluo Granule for Stroke

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