Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Not Applicable

• Conditions: Brain Hypoperfusion Syndrome; Ischemia Brain

• Registration Number: NCT01221662
• Lead Sponsor: China Medical University Hospital

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 .

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-10
• Study First Submitted: 2010-10-10
• Study First Submitted QC: 2010-10-14
• Last Update Submitted: 2010-10-14
• Study First Posted: 2010-10-15
• Last Update Posted: 2010-10-15
• Primary Completion: 2012-07
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
cerebral blood flow	12 weeks after treatment	Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)

Secondary Outcome Measures

Name	Time	Method
severity of dizziness	12 weeks after treatment	severity of dizziness by using visual analogue scale (VAS)
cognitive function	12 weeks after treatment	cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)
quality of life	12 weeks after treatment	quality of life by using barthel index (BI) and Functional Independent Measure (FIM)

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan