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Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

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ClinicalTrials.gov Identifier: NCT01221662
Recruitment Status : Unknown
Verified October 2010 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : October 15, 2010
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
China Medical University Hospital

Brief Summary:
Brain hypoperfusion patients may cause vascular dementia results from their hypoperfusion state except that is a risk factor for stroke. The most common clinical symptom of hypoperfusion syndrome is dizziness.Siwu tang is made of Angelica sinensis (Oliv.) Diels (當歸), Rehmannia glutinosa (Gaertn) Libosch (熟地黃), Paeonia lactiflora Pall (白芍), Ligusticum chuanxiong Hort (川芎), and that was used to treat patients with blood deficiency for several centuries. the purpose of the present study was to investigate the complementary effect of siwu tang on brain hypoperfusion syndrome patients

Condition or disease Intervention/treatment Phase
Brain Hypoperfusion Syndrome Ischemia Brain Drug: Siwu Tang Not Applicable

Detailed Description:

We designed a randomized, double-blinded controlled study, and a total of 80 patients with brain hypoperfusion syndrome should be finished assessment in two years. The 80 patients with hypoperfusion syndrome were divided into as follows:1) control group, receiving siwu tang placebo 3 g bid continuously two weeks except ordinary treatment; 2) treatment group, receiving siwu tang 3 g bid continuously two weeks except ordinary treatment. The patients were assessed before, and 4 weeks (weeks±3 days) and 12 weeks (12 weeks±3 days) after siwu tang treatment, respectively. Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT); Second outcome measure included severity of dizziness by using visual analogue scale (VAS); cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR); quality of life by using barthel index (BI) and Functional Independent Measure (FIM).

We predict that siwu tang can improve cerebral blood flow, and clinical manifestation including dizziness, and cognition function and quality of life in patients with brain hypoperfusion syndrome .


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Siwu Tang
    Siwu Tang 3 g bid(oral) continuously two weeks


Primary Outcome Measures :
  1. cerebral blood flow [ Time Frame: 12 weeks after treatment ]
    Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)


Secondary Outcome Measures :
  1. severity of dizziness [ Time Frame: 12 weeks after treatment ]
    severity of dizziness by using visual analogue scale (VAS)

  2. cognitive function [ Time Frame: 12 weeks after treatment ]
    cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)

  3. quality of life [ Time Frame: 12 weeks after treatment ]
    quality of life by using barthel index (BI) and Functional Independent Measure (FIM)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18y/o to 80 y/o and had brain hypoperfusion syndrome such as dizziness
  • barthel index (BI) > 60。
  • single photon emission computer tomography(SPECT) or MRI exam show hypoperfusion area

Exclusion Criteria:

  • Patient had cancer or uremia,liver cirrhosis

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): NCT01221662


Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Chun-Chung Chen, MD    886-4-22052121 ext 5034    cck36701@gmail.com   
Principal Investigator: Chun-Chung Chen, MD         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Director: Chun-Chung Chen, master China Medical University Hospital

Responsible Party: Chun-Chung Chen, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01221662     History of Changes
Other Study ID Numbers: DMR98-IRB-282
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010

Keywords provided by China Medical University Hospital:
Siwu tang
brain hypoperfusion
cognition function

Additional relevant MeSH terms:
Syndrome
Ischemia
Brain Ischemia
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases