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Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01221662
Enrollment
80
Registered
2010-10-15
Start date
2010-07-31
Completion date
2012-11-30
Last updated
2010-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Hypoperfusion Syndrome, Ischemia Brain

Keywords

Siwu tang, brain hypoperfusion, cognition function

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 .

Interventions

Siwu Tang 3 g bid(oral) continuously two weeks

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
cerebral blood flow12 weeks after treatmentPrimary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)

Secondary

MeasureTime frameDescription
severity of dizziness12 weeks after treatmentseverity of dizziness by using visual analogue scale (VAS)
cognitive function12 weeks after treatmentcognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)
quality of life12 weeks after treatmentquality of life by using barthel index (BI) and Functional Independent Measure (FIM)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026