Evaluate the Efficacy of Bu-Yang- Huan-Wu Tang（BYHWT）on Ischemic Stroke

May 27, 2014 updated by: China Medical University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
42days and 84days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
42days and 84days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH102-REC1-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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