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

NCT ID: NCT01554787

Last Updated: 2012-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chinese Herb Astragalus membranaceus

Group Type EXPERIMENTAL

Chinese Herb Astragalus membranaceus

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

at a rate of 2.8g three times per day

Interventions

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Chinese Herb Astragalus membranaceus

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

Intervention Type DRUG

Placebo

at a rate of 2.8g three times per day

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chung Hsiang Liu, MD.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chung Hsiang Liu, MD.

Role: CONTACT

886-4-22052121 ext. 7635

Facility Contacts

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Chung Hsiang Liu, MD.

Role: primary

Other Identifiers

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DMR100-IRB-251

Identifier Type: -

Identifier Source: org_study_id

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