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

March 13, 2012 updated by: China Medical University Hospital

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Chung Hsiang Liu, MD.
        • Principal Investigator:
          • Chung Hsiang Liu, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
at a rate of 2.8g three times per day
Experimental: Chinese Herb Astragalus membranaceus
Drug: Chinese Herb Astragalus membranaceus
Astragalus membranaceus(AM)at a rate of 2.8g three times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EORTC QLQ-C30
Time Frame: 2 year(all patients)
2 year(all patients)
BFI-T score
Time Frame: 2 years(all patients)
2 years(all patients)

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36 score
Time Frame: 2 years(all patients)
2 years(all patients)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Chung Hsiang Liu, MD., China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMR100-IRB-251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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