title: Panax ginseng C.A Meyer root extract for moderate chronic obstructive pulmonary disease (COPD): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Chronic obstructive pulmonary disease (COPD) impairs quality of life and leads to premature mortality. COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities. Ginseng has been used for thousands of years in Chinese medicine for respiratory symptoms. Several controlled clinical trials using ginseng for COPD have shown promising clinical effect, however these studies were generally small and with some potential bias, prompting the need for rigorously designed studies.
  
  
  OBJECTIVE
  The objective of this study is to evaluate the therapeutic value and safety profile of a standardised root extract of Panax ginseng C.A Meyer (ginseng) for symptomatic relief, with a focus on quality of life (QoL) improvements in individuals with moderate (Stage II) COPD FEV1/FVC < 0.7 and FEV₁ 50%-80% predicted.
  
  
  METHODS
  This paper describes the design of a randomised, multi-centre, double-blind, placebo controlled, two-armed parallel clinical trial. Two trial sites in Melbourne Australia will proportionately randomise a total of 168 participants to receive either ginseng capsule (100 mg) or matching placebo twice daily for 24 weeks. The primary outcomes will be based on three validated QoL questionnaires, St Georges Respiratory Questionnaire (SGRQ), Short Form Health Survey (SF-36) and the COPD Assessment Test (CAT). Secondary outcomes are based on lung function testing, relief medication usage and exacerbation frequency and severity. Safety endpoints include blood tests and adverse event reporting. Intention-to-treat will be applied to all data analyses.
  
  
  CONCLUSIONS
  Findings from this study may lead to new therapeutic development for chronic respiratory diseases, particularly COPD. This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000768099.
authors: Discipline of Chinese Medicine, School of Health Sciences and Health Innovations Research Institute (HIRi), RMIT University, Bundoora, VIC, Australia. charlie.xue@rmit.edu.au
authors: Charlie C
authors: CC
authors: Xue
authors: Johannah L
authors: JL
authors: Shergis
authors: Anthony L
authors: AL
authors: Zhang
authors: Christopher
authors: C
authors: Worsnop
authors: Harry
authors: H
authors: Fong
authors: David
authors: D
authors: Story
authors: Cliff
authors: C
authors: Da Costa
authors: Francis Ck
authors: FC
authors: Thien
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D005894:Panax; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D018517:Plant Roots; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012107:Research Design; D019141:Respiratory System Agents / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013147:Spirometry; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014739:Victoria; D014797:Vital Capacity
chemical_list: D010936:Plant Extracts; D019141:Respiratory System Agents