Effectiveness and Safety of Yiqitongluo Granule for Stroke

Yi Yang

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Drug: Yiqitongluo granule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02604654

SWYY-YQTLKL

Details and patient eligibility

About

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.

Enrollment: 2,197 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,197 participants in 1 patient group

Yiqitongluo group

Experimental group

Description:

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

Treatment:

Drug: Yiqitongluo granule