Evaluate the Efficacy of Bu-Yang- Huan-Wu Tang（BYHWT）on Ischemic Stroke
NCT ID: NCT02150252
Last Updated: 2014-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2014-05-31
2016-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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BY HWT，placebo-BY HWT ， Gait parameter
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Stroke is first time
3. Between 15 and 90 day after stroke onset
4. NIHSS score between 5 and 20
5. NIHSS: 6th item, motor function (lower extremities) ≦3
6. Walking is at least 10 meters.
Exclusion Criteria
2. NIHSS: 6th item, motor function (lower extremities) = 0 (lift 30 degree more than 5 second in supine position)
3. Cannot intake food from oral or intake food complete depend on helper
4. Acute stroke onset within 14 days
5. Gait disturbance due to other factor, such as Parkinson disease, spinal injury, knee joint disorders etc.
6. Cerebellar stroke
7. Pregnancy or lactation
8. Over irritability or anxiety results in cannot assessment
9. Severe traumatic injury or head surgery history
10. Stroke due to cerebral venous thrombosis
11. Systemic disease such as uremia, chronic obstructive pulmonary disorders, or heart failure NYHA ≧ (third degree: mild activity induces dyspnea; fourth degree: dyspnea feeling under rest state)
12. Severe psychiatric disorders such as depression, schizophrenia etc.
40 Years
75 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Locations
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China Medical University Hospital
Taichung, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH102-REC1-122
Identifier Type: -
Identifier Source: org_study_id
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