CompletedPhase 2ACTRN12610000768099

Ginseng extract for patients with moderate Chronic Obstructive Pulmonary Disease (COPD)

The effect of a standardised ginseng extract on the quality of life and respiratory symptoms of patients with moderate chronic obstructive pulmonary disease: a multi-centre, randomised, double-blind, placebo controlled trial

Sponsor

Royal Melbourne Institute of Technology (RMIT) University

Enrollment

168 participants

Start Date

Dec 13, 2010

Study Type

Interventional

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Summary

This study will investigate the safety profile and efficacy of a standardised extract of Panax ginseng with a focus on quality of life improvements in adults with moderate chronic obstructive pulmonary disease. The study is a multi-centre, randomised, double-blind, placebo-controlled clinical trial. The study will consist of three phases: a run in period of 4 weeks, 24 weeks of treatment and 24 weeks of follow-up.

Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Inclusion Criteria7

Both male and female, aged 40 years and over;
Smokers and ex-smokers;
Satisfy the COPD diagnostic criteria for moderate (stage II) defined by the Global initiative for chronic Obstructive Lung Disease (GOLD),
FEV1/ FVC ratio < 0.7 (post-bronchodilator value) and, FEV1 between 50% and 80%;
Are clinically stable, that is, did not experience an acute infective exacerbation of COPD from at least 4 weeks prior to trial entry;
Meet the Chinese Medicine diagnostic criteria for Lung Qi deficiency or Lung & Spleen Qi deficiency;
Informed written consent for participation in the study.

Exclusion Criteria1

Current smokers; 2. Those who have been diagnosed as alpha1-antitrypsin deficient; 3. A reduction in FEV1 > 12% and 200mls or a 4 point or more worsening of their SGRQ compared to baseline or FEV1 < 50% at visit 2 (week 4); 4. Those with a history of current asthma or a history of chronic systemic infections or inflammatory conditions in the last 3 months; 5. Pregnancy, breast-feeding or women intending to become pregnant during the course of the study; 6. Those with serious illnesses, which make them unsuitable for the study, e.g., severe heart, liver and kidney diseases; 7. Individuals unable to adequately perform spirometry tests; 8. Those who are taking long-term immunosuppressive agents or immuno-stimulants; 9. Individuals with an allergic history to ginseng products; 10. Those currently using a ginseng-containing product or have used a ginseng product within the last three months; 11. Those who are current users of monoamine oxidase inhibitor antidepressants, anticoagulants and antihyperglycaemic medications; 12. Individuals having pulmonary rehabilitation within three months of the commencement of the study, or intend to enter pulmonary rehabilitation during the study.

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