Evaluate the Efficacy of Bu-Yang- Huan-Wu Tang（BYHWT）on Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT02150252|
Recruitment Status : Unknown
Verified May 2014 by China Medical University Hospital.
Recruitment status was: Recruiting
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
- Clinical trial; Ischemic stroke; Bu-Yang-Huan-Wu Tang （BYHWT）; Gait parameter; Quality of life Stroke is the third of ten causing death disease constantly, and it also is third of consuming healthy insurance budget. There is 17,000 peoples disable due to stroke every year in Taiwan. Although ischemic stroke patient may use t-PA intravenously treatment within 3 hrs after stroke onset in modern medicine, and no others method may effect to treat ischemic stroke patients, thus, the study about stroke is an important issue. Bu-Yang- Huan-Wu Tang (BYHWT) has been became a main stream for the treatment of stroke after Qing dynasty Wang Qing-Ren theory that is BYHWT may treat stroke due to pattern of qi stagnation and blood stasis in traditional Chinese medicine. A number of researches report that BYHWT can reduce blood viscosity, anti-inflammation, enhancing neuronal regeneration and angiogenesis, but above-mentioned about BYHWT limit in the level of animal study and the scientific evidence is insufficiency in human trial. Therefore, the purpose of the present study was to investigate the therapeutic effect of BYHWT treating ischemic stroke by using a strict clinical trial.
- We designed a randomized, double blind, placebo-controlled study to assess the therapeutic effect of BYHWT treating ischemic stroke. The study expects to finish the assessment of 120 patients with ischemic stroke in three years. The study divided into: 1) control group, receive placebo-BYHWT 3.0 g TID every day for continuously 6 weeks except ordinary medical care; 2) treatment group, the method is identical control group, but receive BYHWY. The main outcome was according to the changes of gait parameter including Speed, Cadence, Strike length, Gait cycle and Double support; and secondary outcome including the changes of Functional independence measurement scores and Barthel index scores, Ten Meters Walk Test, Short Physical Performance Batter, Berg Balance Test and WHO quality of life-brief (Taiwan Brief).
- We predict the results of the present can provide scientific evidence to proof BYHWT can improve neurological deficit and also can improve quality of life in patients with ischemic stroke.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: Bu-Yang-Huan-Wu Tang||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Bu-Yang-Huan-Wu Tang（BYHWT）on Ischemic Stroke|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
|Experimental: BY HWT，placebo-BY HWT ， Gait parameter||
Drug: Bu-Yang-Huan-Wu Tang
control group,Recruited patients should be received the placebo-BYHWT 3.0 g TID every day for continuously 6 weeks except ordinary medical care; 2) treatment group, the method is identical control group
- Gait parameter [ Time Frame: 42days and 84days ]The main outcome was according to the changes of gait parameter including Speed, Cadence, Strike length, Gait cycle and Double support.
- Functional independence measurement scores and Barthel index scores, Ten Meters Walk Test, Short Physical Performance Batter, Berg Balance Test and WHO quality of life-brief (Taiwan Brief). [ Time Frame: 42days and 84days ]
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): NCT02150252
|Contact: Ching-Liang Hsieh, M.D., Ph.D||+886-4-22053366 ext firstname.lastname@example.org|
|China Medical University Hospital||Recruiting|
|Taichung, Taiwan, 40447|
|Contact: Ching-Liang Hsieh, M.D., Ph.D +886-4-22053366 ext 3500 email@example.com|