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

China Medical University

Status and phase: Unknown; Phase 4

Conditions: Stroke; Fatigue

Treatments: Drug: Chinese Herb Astragalus membranaceus; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01554787

DMR100-IRB-251

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Chinese Herb Astragalus membranaceus

Experimental group

Treatment:

Drug: Chinese Herb Astragalus membranaceus

Placebo

Placebo Comparator group

Treatment:

Other: Placebo