Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

October 14, 2010 updated by: China Medical University Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Siwu Tang

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

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

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

Study Locations

Taiwan
- - Taichung, Taiwan, 404
    - Recruiting
    - China Medical University Hospital
    - Contact:
      
      Chun-Chung Chen, MD
      
      Phone Number: 5034 886-4-22052121
      
      Email: cck36701@gmail.com
    - Principal Investigator:
      
      Chun-Chung Chen, MD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebral blood flow Time Frame: 12 weeks after treatment	Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)	12 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of dizziness Time Frame: 12 weeks after treatment	severity of dizziness by using visual analogue scale (VAS)	12 weeks after treatment
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)	12 weeks after treatment
quality of life Time Frame: 12 weeks after treatment	quality of life by using barthel index (BI) and Functional Independent Measure (FIM)	12 weeks after treatment

Collaborators and Investigators

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

Sponsor

China Medical University Hospital

Investigators

Study Director: Chun-Chung Chen, master, 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

July 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

October 10, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)