Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
This study is currently recruiting participants.
Verified March 2012 by China Medical University Hospital
Sponsor:
China Medical University Hospital
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
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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:
- Gender: Male or female.
- Age: between 40 and 80 years old.
- Three months after stroke.
- Hemorrhagic stroke or ischemic stroke.
- Fatigue score from screen process ≧4.
- Subject with comprehension or communication.
- Volunteer signs the agreement to participate the study after whole study purpose and procedures description in detail.
Exclusion Criteria:
- People from mental illness can not to participate the evaluation.
- Major diseases such as cancer、Chronic pulmonary obstructive disease(COPD)、 Heart failure、Myocardial Infraction、Chronic renal failure or Liver cirrhosis.
- Pregnant woman.
- Breast-feeding woman.
Contacts and Locations
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 June 18, 2013