Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Brain Hypoperfusion Syndrome Clinical Trial

Official title:

Complementary Therapy of Siwu Tang on Patients With Brain Hypoperfusion Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01221662
• Other study ID #: DMR98-IRB-282
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2010
• Last updated: October 14, 2010
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2010
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Hypoperfusion Syndrome
• Brain Ischemia
• Ischemia Brain
• Syndrome

Intervention

Drug:
• Siwu Tang
Siwu Tang 3 g bid(oral) continuously two weeks

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral blood flow	Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)	12 weeks after treatment	No
Secondary	severity of dizziness	severity of dizziness by using visual analogue scale (VAS)	12 weeks after treatment	No
Secondary	cognitive function	cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR)	12 weeks after treatment	No
Secondary	quality of life	quality of life by using barthel index (BI) and Functional Independent Measure (FIM)	12 weeks after treatment	No