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Effectiveness and Safety of Yiqitongluo Granule for Stroke

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ClinicalTrials.gov Identifier: NCT02604654
Recruitment Status : Unknown
Verified November 2015 by Yi Yang, First Hospital of Jilin University.
Recruitment status was:  Enrolling by invitation
First Posted : November 13, 2015
Last Update Posted : November 23, 2015
Sponsor:
Collaborator:
Shineway Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
Yi Yang, First Hospital of Jilin University

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Yiqitongluo granule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Yiqitongluo group
Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.
Drug: Yiqitongluo granule
administered after dissolved




Primary Outcome Measures :
  1. Safety of Yiqitongluo for stroke measured by laboratory index [ Time Frame: change from baseline laboratory index at 28(±7) days ]

Secondary Outcome Measures :
  1. Effect of Yiqitongluo for stroke with mRS [ Time Frame: 90(±7) days ]
    mRS: modified Rankin Scale

  2. Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine [ Time Frame: 28(±7) days ]
  3. Effect of Yiqitongluo for stroke with NIHSS [ Time Frame: 28(±7) days ]
    NIHSS: the NIH stroke scale

  4. Effect of Yiqitongluo for stroke with BI [ Time Frame: 28(±7) days ]
    BI: Barthel Index

  5. Effect of Yiqitongluo for stroke with EQ-5D [ Time Frame: 28(±7) days ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604654


Sponsors and Collaborators
Yi Yang
Shineway Pharmaceutical Co.,Ltd
Investigators
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Study Chair: Yi Yang First Hospital of Jilin University
Study Director: Zhenni Guo First Hospital of Jilin University

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Responsible Party: Yi Yang, Associated Dean of First Hospital of Jilin University, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02604654     History of Changes
Other Study ID Numbers: SWYY-YQTLKL
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases