Effectiveness and Safety of Yiqitongluo Granule for Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02604654|
Recruitment Status : Unknown
Verified November 2015 by Yi Yang, First Hospital of Jilin University.
Recruitment status was: Enrolling by invitation
First Posted : November 13, 2015
Last Update Posted : November 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Yiqitongluo granule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||May 2017|
Experimental: Yiqitongluo group
Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.
Drug: Yiqitongluo granule
administered after dissolved
- Safety of Yiqitongluo for stroke measured by laboratory index [ Time Frame: change from baseline laboratory index at 28(±7) days ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604654
|Study Chair:||Yi Yang||First Hospital of Jilin University|
|Study Director:||Zhenni Guo||First Hospital of Jilin University|