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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

October 10, 2010
October 14, 2010
July 2010
July 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01221662 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome
Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome

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

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 .
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Brain Hypoperfusion Syndrome
  • Ischemia Brain
Drug: Siwu Tang
Siwu Tang 3 g bid(oral) continuously two weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
November 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Not Provided
Taiwan
 
NCT01221662
DMR98-IRB-282
Yes
Chun-Chung Chen, China Medical University Hospital
China Medical University Hospital
Not Provided
Study Director: Chun-Chung Chen, master China Medical University Hospital
China Medical University Hospital
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP