Clinical trial NCT01221662: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Hypoperfusion Syndrome
Ischemia Brain
Keywords: Siwu tang
brain hypoperfusion
cognition function
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: cerebral blood flow
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: severity of dizziness
timeFrame: 12 weeks after treatment
measure: cognitive function
timeFrame: 12 weeks after treatment
measure: quality of life
timeFrame: 12 weeks after treatment
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Chun-Chung Chen, master
role: STUDY_DIRECTOR
References: