NCT01221662

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 15, 2010

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

October 10, 2010

Last Update Submit

October 14, 2010

Conditions

Brain Hypoperfusion SyndromeIschemia Brain

Keywords

Siwu tangbrain hypoperfusioncognition function

Outcome Measures

Primary Outcomes (1)

  • cerebral blood flow

    Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT)

    12 weeks after treatment

Secondary Outcomes (3)

  • severity of dizziness

    12 weeks after treatment

  • cognitive function

    12 weeks after treatment

  • quality of life

    12 weeks after treatment

Interventions

Siwu TangDRUG

Siwu Tang 3 g bid(oral) continuously two weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient had cancer or uremia,liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chun-Chung Chen, master

    China Medical University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2010

First Posted

October 15, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

October 15, 2010

Record last verified: 2010-10

Locations

TW(1)