Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02150252
Status:
UNKNOWN
Last Update Posted:
2014-05-29
First Post:
2014-05-27
Brief Title:
Evaluate the Efficacy of Bu-Yang- Huan-Wu TangBYHWTon Ischemic Stroke
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Randomized Double Blind Placebo Control Trial to Evaluate the Efficacy of Bu-Yang-Huan-Wu TangBYHWTon Ischemic Stroke
Status:
UNKNOWN
Status Verified Date:
2014-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 17000 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 30 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
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 30 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None