Ischemic StrokePhase 2NCT02150252
Evaluate the Efficacy of Bu-Yang- Huan-Wu Tang（BYHWT）on Ischemic Stroke
A Phase 2 study testing Bu-Yang-Huan-Wu Tang in people with Ischemic Stroke, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Bu-Yang-Huan-Wu Tang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧40 and ≦75
- Stroke is first time
- Between 15 and 90 day after stroke onset
- NIHSS score between 5 and 20
- NIHSS: 6th item, motor function (lower extremities) ≦3
- Walking is at least 10 meters.
Who cannot join
- Intake anticoagulant agent within one week, such as Heparin, warfarin etc.
- NIHSS: 6th item, motor function (lower extremities) = 0 (lift 30 degree more than 5 second in supine position)
- Cannot intake food from oral or intake food complete depend on helper
- Acute stroke onset within 14 days
- Gait disturbance due to other factor, such as Parkinson disease, spinal injury, knee joint disorders etc.
- Cerebellar stroke
Show all 12Show fewer
- Pregnancy or lactation
- Over irritability or anxiety results in cannot assessment
- Severe traumatic injury or head surgery history
- Stroke due to cerebral venous thrombosis
- 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)
- Severe psychiatric disorders such as depression, schizophrenia etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Taiwan, 40447
Ching-Liang Hsieh, M.D., Ph.D, +886-4-22053366 ext. 3500, clhsieh@mail.cmuh.org.tw
About this study
Official title: Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Bu-Yang-Huan-Wu Tang（BYHWT）on Ischemic Stroke
- 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.
- Conditions
- Ischemic Stroke
- Being tested
- Bu-Yang-Huan-Wu Tang
- Keywords
- Clinical trial, Ischemic stroke, Bu-Yang-Huan-Wu Tang (BYHWT）, Gait parameter, Quality of life
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bu-Yang-Huan-Wu TangDrug
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
| Study group | Role | What they receive |
|---|---|---|
| BY HWT，placebo-BY HWT ， Gait parameter | Experimental | Not described Receives: Drug: Bu-Yang-Huan-Wu Tang |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameter
The main outcome was according to the changes of gait parameter including Speed, Cadence, Strike length, Gait cycle and Double support.
Measured: 42days and 84days
Secondary outcomes (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).
Measured: 42days and 84days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150252
- Sponsor's protocol ID
- CMUH102-REC1-122
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Bu-Yang-Huan-Wu Tang（BYHWT）on Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02150252
- Acronym / sponsor ID
- CMUH102-REC1-122
- Conditions
- Ischemic Stroke
- Keywords
- Clinical trial, Ischemic stroke, Bu-Yang-Huan-Wu Tang (BYHWT）, Gait parameter, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BY HWT，placebo-BY HWT ， Gait parameter | Experimental | Drug: Bu-Yang-Huan-Wu Tang |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≧40 and ≦75
- Stroke is first time
- Between 15 and 90 day after stroke onset
- NIHSS score between 5 and 20
- NIHSS: 6th item, motor function (lower extremities) ≦3
Key exclusion criteria (12 listed)
- Intake anticoagulant agent within one week, such as Heparin, warfarin etc.
- NIHSS: 6th item, motor function (lower extremities) = 0 (lift 30 degree more than 5 second in supine position)
- Cannot intake food from oral or intake food complete depend on helper
- Acute stroke onset within 14 days
- Gait disturbance due to other factor, such as Parkinson disease, spinal injury, knee joint disorders etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bu-Yang-Huan-Wu Tangcontrol 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 | Drug | BY HWT，placebo-BY HWT ， Gait parameter |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bu-Yang-Huan-Wu Tang in people with Ischemic Stroke, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Liang Hsieh, M.D., Ph.D (+886-4-22053366 ext. 3500, clhsieh@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameter (time frame: 42days and 84days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.