Effectiveness and Safety of Yiqitongluo Granule for Stroke

August 19, 2021 updated by: Yi Yang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2197

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of Yiqitongluo for stroke measured by laboratory index
Time Frame: change from baseline laboratory index at 28(±7) days
change from baseline laboratory index at 28(±7) days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Yiqitongluo for stroke with mRS
Time Frame: 90(±7) days
mRS: modified Rankin Scale
90(±7) days
Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine
Time Frame: 28(±7) days
28(±7) days
Effect of Yiqitongluo for stroke with NIHSS
Time Frame: 28(±7) days
NIHSS: the NIH stroke scale
28(±7) days
Effect of Yiqitongluo for stroke with BI
Time Frame: 28(±7) days
BI: Barthel Index
28(±7) days
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.
28(±7) days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Yang

Collaborators

Shineway Pharmaceutical Co.,Ltd

Investigators

  • Study Chair: Yi Yang, The First Hospital of Jilin University
  • Study Director: Zhenni Guo, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2015

Primary Completion (Actual)

November 5, 2017

Study Completion (Actual)

December 6, 2017

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWYY-YQTLKL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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