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Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Primary Purpose

Brain Hypoperfusion Syndrome, Ischemia Brain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Siwu Tang
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Hypoperfusion Syndrome focused on measuring Siwu tang, brain hypoperfusion, cognition function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University HospitalRecruiting

Outcomes

Primary Outcome Measures

cerebral blood flow
Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)

Secondary Outcome Measures

severity of dizziness
severity of dizziness by using visual analogue scale (VAS)
cognitive function
cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)
quality of life
quality of life by using barthel index (BI) and Functional Independent Measure (FIM)

Full Information

First Posted
October 10, 2010
Last Updated
October 14, 2010
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01221662
Brief Title
Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome
Official Title
Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Hypoperfusion Syndrome, Ischemia Brain
Keywords
Siwu tang, brain hypoperfusion, cognition function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Siwu Tang
Intervention Description
Siwu Tang 3 g bid(oral) continuously two weeks
Primary Outcome Measure Information:
Title
cerebral blood flow
Description
Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)
Time Frame
12 weeks after treatment
Secondary Outcome Measure Information:
Title
severity of dizziness
Description
severity of dizziness by using visual analogue scale (VAS)
Time Frame
12 weeks after treatment
Title
cognitive function
Description
cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)
Time Frame
12 weeks after treatment
Title
quality of life
Description
quality of life by using barthel index (BI) and Functional Independent Measure (FIM)
Time Frame
12 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Chung Chen, master
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Chung Chen, MD
Phone
886-4-22052121
Ext
5034
Email
cck36701@gmail.com
First Name & Middle Initial & Last Name & Degree
Chun-Chung Chen, MD

12. IPD Sharing Statement

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Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

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