Effectiveness and Safety of Yiqitongluo Granule for Stroke

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Yiqitongluo granule

• Registration Number: NCT02604654
• Lead Sponsor: Yi Yang

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 available

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Study Start: 2015-12-29
• Primary Completion: 2017-11-05
• Study Completion: 2017-12-06
• Status Verified: 2020-07
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2197

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yiqitongluo group	Yiqitongluo granule	Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of Yiqitongluo for stroke with mRS	90(±7) days	mRS: modified Rankin 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.
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