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

China Medical University Hospital90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fatigue Stroke

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

EORTC QLQ-C30

Time frame: 2 year(all patients)

BFI-T score

Time frame: 2 years(all patients)

Secondary Outcomes

SF-36 score