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
  Purpose

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 Intervention Phase
Fatigue
Stroke
Drug: Chinese Herb Astragalus membranaceus
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • SF-36 score [ Time Frame: 2 years(all patients) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01554787     History of Changes
Other Study ID Numbers: DMR100-IRB-251
Study First Received: March 7, 2012
Last Updated: March 13, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on September 14, 2014