Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Study Overview
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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 .

Official Title
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Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome

Conditions
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Brain Hypoperfusion Syndrome, Ischemia Brain

Intervention / Treatment
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* Drug: Siwu Tang


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Siwu Tang|Siwu Tang 3 g bid(oral) continuously two weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral blood flow | 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 | severity of dizziness by using visual analogue scale (VAS) | 12 weeks after treatment | 
| cognitive function | 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 | quality of life by using barthel index (BI) and Functional Independent Measure (FIM) | 12 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Siwu tang, brain hypoperfusion, cognition function