Effectiveness and Safety of Yiqitongluo Granule for Stroke

Enrolling by invitation

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Yiqitongluo granule Drug
    Intervention Desc: administered after dissolved
    ARM 1: Kind: Experimental
    Label: Yiqitongluo group
    Description: Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Effectiveness of Yiqitongluo for stroke measured by mRS 90(±7) days No
Primary Safety of Yiqitongluo for stroke measured by laboratory index -3-0 days and 28(±7) days Yes
Secondary Effectiveness of Yiqitongluo for stroke measured by other indicators 28(±7) days Yes
Secondary Effect of Yiqitongluo for stroke with mRS 90(±7) days No
Secondary Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine 28(±7) days No
Secondary Effect of Yiqitongluo for stroke with NIHSS 28(±7) days No
Secondary Effect of Yiqitongluo for stroke with BI 28(±7) days No
Secondary Effect of Yiqitongluo for stroke with EQ-5D 28(±7) days No

Sponsors