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 ]
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