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Completed

NCT Number: NCT02604654

Effectiveness and Safety of Yiqitongluo Granule for Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yiqitongluo granule

Drug

administered after dissolved

Primary outcomes

  1. Safety of Yiqitongluo for stroke measured by laboratory index

    Time frame: change from baseline laboratory index at 28(±7) days

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Collaborators

  • Shineway Pharmaceutical Co.,Ltd

Registry information

Official study title

Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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