NCT02604654

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,197

participants targeted

Target at P75+ for phase_4 stroke

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4 stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 29, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2017

Completed
Last Updated

August 25, 2021

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

November 11, 2015

Last Update Submit

August 19, 2021

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Safety of Yiqitongluo for stroke measured by laboratory index

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

Secondary Outcomes (5)

  • Effect of Yiqitongluo for stroke with mRS

    90(±7) days

  • Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine

    28(±7) days

  • Effect of Yiqitongluo for stroke with NIHSS

    28(±7) days

  • Effect of Yiqitongluo for stroke with BI

    28(±7) days

  • Effect of Yiqitongluo for stroke with EQ-5D

    28(±7) days

Study Arms (1)

Yiqitongluo group

EXPERIMENTAL

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

Drug: Yiqitongluo granule

Interventions

Yiqitongluo granuleDRUG

administered after dissolved

Yiqitongluo group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yi Yang

    The First Hospital of Jilin University

    STUDY CHAIR

  • Zhenni Guo

    The First Hospital of Jilin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of First Hospital of Jilin University

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 13, 2015

Study Start

December 29, 2015

Primary Completion

November 5, 2017

Study Completion

December 6, 2017

Last Updated

August 25, 2021

Record last verified: 2020-07