Clinical Trial: Effectiveness and Safety of Yiqitongluo Granule for Stroke

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:
Sponsor: Yi Yang

Current Primary Outcome: Safety of Yiqitongluo for stroke measured by laboratory index [ Time Frame: change from baseline laboratory index at 28(±7) days ]

Original Primary Outcome:

  • Effectiveness of Yiqitongluo for stroke measured by mRS [ Time Frame: 90(±7) days ]
  • Safety of Yiqitongluo for stroke measured by laboratory index [ Time Frame: -3-0 days and 28(±7) days ]


Current Secondary Outcome:

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


Original Secondary Outcome: Effectiveness of Yiqitongluo for stroke measured by other indicators [ Time Frame: 28(±7) days ]

syndrome of traditional Chinese medicine; NIHSS; BI; EQ-5D


Information By: First Hospital of Jilin University

Dates:
Date Received: November 11, 2015
Date Started: November 2015
Date Completion: May 2017
Last Updated: November 20, 2015
Last Verified: November 2015