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

Phase 4

• Conditions: Fatigue; Stroke
• Interventions: Drug: Chinese Herb Astragalus membranaceus; Other: Placebo

• Registration Number: NCT01554787
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Study First Posted: 2012-03-15
• Last Update Posted: 2012-03-15
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese Herb Astragalus membranaceus	Chinese Herb Astragalus membranaceus	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	2 year(all patients)
BFI-T score	2 years(all patients)

Secondary Outcome Measures

Name	Time	Method
SF-36 score	2 years(all patients)

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan