NCT01669759

Brief Summary

The purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

August 14, 2012

Last Update Submit

August 20, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frome Fatigue severity level scale to evaluate fatigue severity score.

    When patient visit first time,we complete all the evaluation scale. Total evaluation time is about 20 minutes. And all data will be analyzed one year later.

    about 20 minutes

Study Arms (1)

fatigue

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with post-stroke fatigue were enrolled from the departments of neurological, neurosurgical, and rehabilitation in China Medical University Hospital (Taichung, Taiwan), their Brief Fatigue Inventory-Taiwan form score ≥ 4, and stroke onset more than 3 months.

You may qualify if:

  • Gender: men or women
  • Age:40\~80 years old
  • Stroke history at least 3 months
  • Hemorrhage or ischemic stoke
  • Conscious clear and can communicate
  • Brief Fatigue Inventory-Taiwan form score ≥ 4
  • Sign informed consent

You may not qualify if:

  • Patient with psychotic diagnosis and can't cooperate with researcher
  • Major disease: chronic obstructive pulmonary disease, heart failure, myocardial infarction, chronic renal failure, liver cirrhosis
  • Pregnant women
  • Breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 40447, Taiwan

RECRUITING

Central Study Contacts

Yuan-Chen Chiu, Master of Chinese Medicine

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 21, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations