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Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue

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ClinicalTrials.gov Identifier: NCT01554787
Recruitment Status : Unknown
Verified March 2012 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The high levels of fatigue in stroke patients without neurological impairment suggest it has a central origin rather than being the result of increased physical effort required after stroke(Winward et al., 2009). Fatigue is different from post-stroke depression and the more serious stroke patients are more prone to fatigue(Windward et al., 2009).

Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most effective of all traditional Chinese medicine and can tonifying middle and tonify the original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus membranaceus on post-stroke fatigue.


Condition or disease Intervention/treatment Phase
Fatigue Stroke Drug: Chinese Herb Astragalus membranaceus Other: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Chinese Herb Astragalus membranaceus Drug: Chinese Herb Astragalus membranaceus
Astragalus membranaceus(AM)at a rate of 2.8g three times per day
Placebo Comparator: Placebo Other: Placebo
at a rate of 2.8g three times per day


Outcome Measures

Primary Outcome Measures :
  1. EORTC QLQ-C30 [ Time Frame: 2 year(all patients) ]
  2. BFI-T score [ Time Frame: 2 years(all patients) ]

Secondary Outcome Measures :
  1. SF-36 score [ Time Frame: 2 years(all patients) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gender: Male or female.
  2. Age: between 40 and 80 years old.
  3. Three months after stroke.
  4. Hemorrhagic stroke or ischemic stroke.
  5. Fatigue score from screen process ≧4.
  6. Subject with comprehension or communication.
  7. Volunteer signs the agreement to participate the study after whole study purpose and procedures description in detail.

Exclusion Criteria:

  1. People from mental illness can not to participate the evaluation.
  2. Major diseases such as cancer、Chronic pulmonary obstructive disease(COPD)、 Heart failure、Myocardial Infraction、Chronic renal failure or Liver cirrhosis.
  3. Pregnant woman.
  4. Breast-feeding woman.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554787


Contacts
Contact: Chung Hsiang Liu, MD. 886-4-22052121 ext 7635 greengen@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Chung Hsiang Liu, MD.         
Principal Investigator: Chung Hsiang Liu, MD.         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chung Hsiang Liu, MD. China Medical University Hospital
More Information

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01554787     History of Changes
Other Study ID Numbers: DMR100-IRB-251
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by China Medical University Hospital:
After stroke with fatigue

Additional relevant MeSH terms:
Stroke
Fatigue
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms