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

Recruiting

Phase 4 Results N/A

Trial Description

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

Interventions

  • Placebo Drug
    Intervention Desc: at a rate of 2.8g three times per day
    ARM 1: Kind: Experimental
    Label: Placebo
  • Chinese Herb Astragalus membranaceus Drug
    Intervention Desc: Astragalus membranaceus(AM)at a rate of 2.8g three times per day
    ARM 1: Kind: Experimental
    Label: Chinese Herb Astragalus membranaceus

Trial Design

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

Outcomes

Type Measure 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

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