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.
Aim
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.
Discussion
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.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000768099
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Details
1 RMIT University, Discipline of Chinese Medicine, School of Health Sciences and Health Innovations Research Institute (HIRi), Bundoora, Australia (GRID:grid.1017.7) (ISNI:0000000121633550)
2 Austin Hospital, Department of Respiratory and Sleep Medicine, Heidelberg, Australia (GRID:grid.414094.c) (ISNI:0000000101627225)
3 RMIT University, Discipline of Chinese Medicine, School of Health Sciences and Health Innovations Research Institute (HIRi), Bundoora, Australia (GRID:grid.1017.7) (ISNI:0000000121633550); University of Illinois at Chicago, Department of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, USA (GRID:grid.185648.6) (ISNI:0000000121750319)
4 RMIT University, School of Mathematical and Geospatial Sciences, Bundoora, Australia (GRID:grid.1017.7) (ISNI:0000000121633550)
5 Box Hill Hospital and Monash University, Department of Respiratory Medicine, Box Hill, Australia (GRID:grid.414580.c) (ISNI:0000000104592144)