Effectiveness and Safety of Yiqitongluo Granule for Stroke | NCT02604654

Studies
Effectiveness and Safety of Yiqitongluo Granule for Stroke

NCT02604654

Sponsor

Yi Yang

Status

Completed

Last Update Posted

Aug 25, 2021Actual

Enrollment

2,197Actual

Phase

Phase 4

Conditions

Stroke

Interventions

Yiqitongluo granule

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2015Actual

Primary Completion Date

Nov 5, 2017Actual

Completion Date

Dec 6, 2017Actual

First Submitted Date

Nov 11, 2015

First Submission Date that Met QC Criteria

Nov 11, 2015

First Posted Date

Nov 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2021

Last Update Posted Date

Aug 25, 2021Actual

Name	Class
Shineway Pharmaceutical Co.,Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,197Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Yiqitongluo group	Experimental	Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.	Drug: Yiqitongluo granule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yiqitongluo granule	Drug	administered after dissolved	Yiqitongluo group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Effect of Yiqitongluo for stroke with mRS	mRS: modified Rankin Scale	90(±7) days
Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine		28(±7) days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yi Yang	The First Hospital of Jilin University	Study Chair
Zhenni Guo	The First Hospital of Jilin University	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided