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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
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≧40 and ≦75
  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:

  1. Intake anticoagulant agent within one week, such as Heparin, warfarin etc.
  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.

Information from the National Library of Medicine

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


Contacts
Contact: Ching-Liang Hsieh, M.D., Ph.D +886-4-22053366 ext 3500 clhsieh@mail.cmuh.org.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Ching-Liang Hsieh, M.D., Ph.D    +886-4-22053366 ext 3500    clhsieh@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02150252     History of Changes
Other Study ID Numbers: CMUH102-REC1-122
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by China Medical University Hospital:
Clinical trial
Ischemic stroke
Bu-Yang-Huan-Wu Tang (BYHWT)
Gait parameter
Quality of life

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia