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

Poststroke Fatigue Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01669759
• Other study ID #: DMR101-IRB2-151
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2012
• Last updated: August 20, 2012
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2012
• Source: China Medical University Hospital
• Contact: Yuan-Chen Chiu, Master of Chinese Medicine
• Phone: 886-4-22053366
• Email: jamy_chiu[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fatigue
• Poststroke Fatigue

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	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	No