The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01669759
First received: August 14, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition
Poststroke Fatigue

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis in Chinese Medicine.

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Frome Fatigue severity level scale to evaluate fatigue severity score. [ Time Frame: about 20 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Detailed Description:

According to the reports of department of Health, stroke has been the top three ranking in leading ten major mortality causes. Although fatigue is a common symptom after stroke, but it is easy to neglect due to fatigue is a non-specific symptom. Based on the literature review, fatigue symptom is not only common on post-stroke patient and it also has highly correlation with mortality, prognosis and efficacy of rehabilitation. In Traditional Chinese Medicine recording, Wang Qing-ren suggests that the main etiology of stroke is results from qi stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis became to the main stream for stroke until now. Therefore, 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient with psychotic diagnosis and can't cooperate with researcher
  2. Major disease: chronic obstructive pulmonary disease, heart failure, myocardial infarction, chronic renal failure, liver cirrhosis
  3. Pregnant women
  4. Breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669759

Contacts
Contact: Yuan-Chen Chiu, Master of Chinese Medicine 886-4-22053366 ext 3600 jamy_chiu@hotmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Ching-Liang Hsieh, professor    886-4-22053366 ext 3600    clhsieh@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01669759     History of Changes
Other Study ID Numbers: DMR101-IRB2-151
Study First Received: August 14, 2012
Last Updated: August 20, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014