Effectiveness and Safety of Yiqitongluo Granule for Stroke

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02604654

Enrollment

2197

Registered

2015-11-13

Start date

2015-12-29

Completion date

2017-12-06

Last updated

2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DRUGYiqitongluo granule

administered after dissolved

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Effect of Yiqitongluo for stroke with mRS	90(±7) days	mRS: modified Rankin Scale
Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine	28(±7) days	—
Effect of Yiqitongluo for stroke with NIHSS	28(±7) days	NIHSS: the NIH stroke scale
Effect of Yiqitongluo for stroke with BI	28(±7) days	BI: Barthel Index
Effect of Yiqitongluo for stroke with EQ-5D	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026