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Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01221662
First received: October 10, 2010
Last updated: October 14, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention
Brain Hypoperfusion Syndrome
Ischemia Brain
 Drug: Siwu Tang

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • cerebral blood flow [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)


Secondary Outcome Measures:
  • severity of dizziness [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    severity of dizziness by using visual analogue scale (VAS)

  • cognitive function [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)

  • quality of life [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    quality of life by using barthel index (BI) and Functional Independent Measure (FIM)


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Siwu Tang
    Siwu Tang 3 g bid(oral) continuously two weeks
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 .

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Chun-Chung Chen, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01221662     History of Changes
Other Study ID Numbers: DMR98-IRB-282
Study First Received: October 10, 2010
Last Updated: October 14, 2010
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013