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

Stroke Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01554787
• Other study ID #: DMR100-IRB-251
• Status: Recruiting
• Phase: Phase 4
• First received: March 7, 2012
• Last updated: March 13, 2012
• Start date: January 2012

Study information

• Verified date: March 2012
• Source: China Medical University Hospital
• Contact: Chung Hsiang Liu, MD.
• Phone: 886-4-22052121
• Email: greengen[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Stroke

Intervention

Drug:
• Chinese Herb Astragalus membranaceus
Astragalus membranaceus(AM)at a rate of 2.8g three times per day

Other:
• Placebo
at a rate of 2.8g three times per day

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ-C30		2 year(all patients)	Yes
Primary	BFI-T score		2 years(all patients)	Yes
Secondary	SF-36 score		2 years(all patients)	Yes