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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01554787
First received: March 7, 2012
Last updated: March 13, 2012
Last verified: March 2012

March 7, 2012
March 13, 2012
January 2012
December 2013   (final data collection date for primary outcome measure)
  • EORTC QLQ-C30 [ Time Frame: 2 year(all patients) ] [ Designated as safety issue: Yes ]
  • BFI-T score [ Time Frame: 2 years(all patients) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01554787 on ClinicalTrials.gov Archive Site
SF-36 score [ Time Frame: 2 years(all patients) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fatigue
  • Stroke
  • Drug: Chinese Herb Astragalus membranaceus
    Astragalus membranaceus(AM)at a rate of 2.8g three times per day
  • Other: Placebo
    at a rate of 2.8g three times per day
  • Experimental: Chinese Herb Astragalus membranaceus
    Intervention: Drug: Chinese Herb Astragalus membranaceus
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
December 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact: Chung Hsiang Liu, MD. 886-4-22052121 ext 7635 greengen@gmail.com
Taiwan
 
NCT01554787
DMR100-IRB-251
Not Provided
China Medical University Hospital
China Medical University Hospital
Not Provided
Principal Investigator: Chung Hsiang Liu, MD. China Medical University Hospital
China Medical University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP