Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Sponsor
China Medical University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01221662
Collaborator
(none)
80
1
28.1
2.9

Study Details

Study Description

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
  • Drug: Siwu Tang
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2010
Anticipated Primary Completion Date :
Jul 1, 2012
Anticipated Study Completion Date :
Nov 1, 2012

Outcome Measures

Primary Outcome Measures

  1. cerebral blood flow [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 [12 weeks after treatment]

    severity of dizziness by using visual analogue scale (VAS)

  2. cognitive function [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 [12 weeks after treatment]

    quality of life by using barthel index (BI) and Functional Independent Measure (FIM)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 China Medical University Hospital Taichung Taiwan 404

Sponsors and Collaborators

  • China Medical University Hospital

Investigators

  • Study Director: Chun-Chung Chen, master, China Medical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01221662
Other Study ID Numbers:
  • DMR98-IRB-282
First Posted:
Oct 15, 2010
Last Update Posted:
Oct 15, 2010
Last Verified:
Oct 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2010