FatiguePhase 4NCT01554787
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
A Phase 4 study testing Chinese Herb Astragalus membranaceus in people with Fatigue and Stroke, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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）. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- Chinese Herb Astragalus membranaceus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Chung Hsiang Liu, MD.
Chung Hsiang Liu, MD.
About this study
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.
- Being tested
- Chinese Herb Astragalus membranaceus, Placebo
- Keywords
- After stroke with fatigue
- Medical subject headings
- Fatigue, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herb Astragalus membranaceusDrug
Astragalus membranaceus(AM)at a rate of 2.8g three times per day
PlaceboOther
at a rate of 2.8g three times per day
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herb Astragalus membranaceus | Experimental | Not described Receives: Drug: Chinese Herb Astragalus membranaceus |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30
Measured: 2 year(all patients)
BFI-T score
Measured: 2 years(all patients)
Secondary outcomes (1)
SF-36 score
Measured: 2 years(all patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung Hsiang Liu, MD., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554787
- Sponsor's protocol ID
- DMR100-IRB-251
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2012
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
- ClinicalTrials.gov ID
- NCT01554787
- Acronym / sponsor ID
- DMR100-IRB-251
- Keywords
- After stroke with fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Herb Astragalus membranaceus | Experimental | Drug: Chinese Herb Astragalus membranaceus |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Herb Astragalus membranaceusAstragalus membranaceus(AM)at a rate of 2.8g three times per day | Drug | Chinese Herb Astragalus membranaceus |
| Placeboat a rate of 2.8g three times per day | Other | Placebo |
Primary outcome
EORTC QLQ-C30
Time frame: 2 year(all patients)
BFI-T score
Time frame: 2 years(all patients)
1 secondary outcome
SF-36 score
Time frame: 2 years(all patients)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Hsiang Liu, MD. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chinese Herb Astragalus membranaceus in people with Fatigue and Stroke, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Hsiang Liu, MD. (886-4-22052121 ext. 7635, greengen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-C30 (time frame: 2 year(all patients)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012; AzTrials last refreshed its copy on 29 Oct 2026.