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

NCT01554787 | Unknown Phase 4

• 1 other identifier: DMR100-IRB-251
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Stroke

Keywords

After stroke with fatigue

Outcome Measures

Primary Outcomes (2)

• EORTC QLQ-C30

  2 year(all patients)

• BFI-T score

  2 years(all patients)

Secondary Outcomes (1)

• SF-36 score

  2 years(all patients)

Study Arms (2)

Chinese Herb Astragalus membranaceus

EXPERIMENTAL

Drug: Chinese Herb Astragalus membranaceus

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Chinese Herb Astragalus membranaceus DRUG

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

Chinese Herb Astragalus membranaceus

Placebo OTHER

at a rate of 2.8g three times per day

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Fatigue; Stroke

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chung Hsiang Liu, MD.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Hsiang Liu, MD.

CONTACT

886-4-22052121; greengen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

TW (1)