Brain Hypoperfusion Syndrome Clinical Trial
Official title:
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
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 .
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment