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Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

NCT ID: NCT01221662

Last Updated: 2010-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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 .

Conditions

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Brain Hypoperfusion Syndrome Ischemia Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Siwu Tang

Siwu Tang 3 g bid(oral) continuously two weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Principal Investigators

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Chun-Chung Chen, master

Role: STUDY_DIRECTOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chun-Chung Chen, MD

Role: primary

[email protected]
886-4-22052121 ext. 5034

Other Identifiers

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DMR98-IRB-282

Identifier Type: -

Identifier Source: org_study_id