1745-6215-12-164.pdf (285.73 kB)

Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial

Download (285.73 kB)
journal contribution
posted on 18.08.2012 by Charlie C. Xue, Johannah L. Shergis, Anthony L. Zhang, Christopher Worsnop, Harry Fong, David Story, Cliff Da Costa, Francis C.K. Thien
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 FEV(1) 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.

Funding

This study is funded by a project grant from the National Health and Medical Research Council (NHMRC) (Project Grant Number: 616609) as well as a seeding grant from the National Institute of Complementary Medicine Australia, and an International Research Grant from the Guangdong Provincial Academy of Chinese Medical Sciences, Guangdong Provincial Hospital of Chinese Medicine, China.

History

Publisher Statement

© 2011 Xue et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. DOI: 10.1186/1745-6215-12-164.

Publisher

BioMed Central

Language

en_US

issn

1745-6215

Issue date

30/06/2011

Exports

Categories

Exports