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Status unknownNCT01554787Updated Mar 15, 2012

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

A Phase 4 interventional study of Chinese Herb Astragalus membranaceus and Placebo in Fatigue and Stroke, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-15.

Sponsored by China Medical University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fatigue
  • Stroke

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Keywords

  • After stroke with fatigue
03

In context

Fatigue

1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.

This study's planned enrollment of 90 is above the median of 53 across 1,479 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Chinese Herb Astragalus membranaceus

    Drug: Chinese Herb Astragalus membranaceus

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugChinese Herb Astragalus membranaceus

    Astragalus membranaceus(AM)at a rate of 2.8g three times per day

  • OtherPlacebo

    at a rate of 2.8g three times per day

06

What researchers measure

Primary outcomes

  1. EORTC QLQ-C30

    Time frame: 2 year(all patients)

  2. BFI-T score

    Time frame: 2 years(all patients)

Secondary outcomes

  1. SF-36 score

    Time frame: 2 years(all patients)

07

Study locations

1 of 1 sites recruiting
  • China Medical University Hospital
    Taichung, Taiwan
    • Chung Hsiang Liu, MD. · Contact
    • Chung Hsiang Liu, MD. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01554787
Responsible party
Sponsor
First posted
Mar 15, 2012
Start date
Jan 2012
Primary completion
Dec 2013 (estimated)
Last update
Mar 15, 2012

Study contacts

Chung Hsiang Liu, MD.
Contact
greengen@gmail.com
886-4-22052121 ext. 7635
Chung Hsiang Liu, MD.
principal investigator · China Medical University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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