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

Primary Purpose

Fatigue, Stroke

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Chinese Herb Astragalus membranaceus
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring After stroke with fatigue

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chinese Herb Astragalus membranaceus

Placebo

Arm Description

Outcomes

Primary Outcome Measures

EORTC QLQ-C30
BFI-T score

Secondary Outcome Measures

SF-36 score

Full Information

First Posted
March 7, 2012
Last Updated
March 13, 2012
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01554787
Brief Title
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Stroke
Keywords
After stroke with fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese Herb Astragalus membranaceus
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chinese Herb Astragalus membranaceus
Intervention Description
Astragalus membranaceus(AM)at a rate of 2.8g three times per day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
at a rate of 2.8g three times per day
Primary Outcome Measure Information:
Title
EORTC QLQ-C30
Time Frame
2 year(all patients)
Title
BFI-T score
Time Frame
2 years(all patients)
Secondary Outcome Measure Information:
Title
SF-36 score
Time Frame
2 years(all patients)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Hsiang Liu, MD.
Phone
886-4-22052121
Ext
7635
Email
greengen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung Hsiang Liu, MD.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung Hsiang Liu, MD.
First Name & Middle Initial & Last Name & Degree
Chung Hsiang Liu, MD.

12. IPD Sharing Statement

Learn more about this trial

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

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