ACTRN12613000382774CompletedPhase 2
The effect of a standardised ginseng extract in patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD): a randomised, double-blind, placebo controlled trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- RMIT University
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •1.Both male and female, aged 40 to 80 (inclusive);
- •2.Satisfy the COPD diagnostic criteria for moderate, severe or very severe (stages II, III & IV) defined by the GOLD, FEV1/ FVC ratio < 0.7 (post-bronchodilator value) and, 20% < FEV1 <80%;
- •3.Are clinically stable, that is, did not experience an acute infective exacerbation of COPD from at least 4 weeks prior to trial entry and, had not been hospitalised in the past 6 months with > 3 acute exacerbations;
- •4.Meet the Chinese Medicine diagnostic criteria for Lung Qi deficiency with or without Spleen Qi deficiency or Kidney Qi deficiency;
- •5.Informed written consent for participation in the study.
Exclusion Criteria
- •1.A reduction in FEV1 > 12% and 200mls or a 4 point or more increase from their SGRQ compared to baseline or FEV1 > 80% at visit 2.
- •2.Those with a history or current asthma or a history of chronic systemic infections or inflammatory conditions that required systematic corticosteroid treatment in the last 3 months;
- •3.Pregnancy, breast-feeding or women intending to become pregnant during the course of the study;
- •4.Those with serious illnesses, which make them unsuitable for the study, e.g., severe heart, liver and kidney diseases;
- •5.Individuals unable to adequately perform spirometry tests;
- •6.Those who are taking long-term immunosuppressive agents or immuno-stimulants;
- •7.Individuals with an allergic history to ginseng products;
- •8.Those currently using a ginseng-containing product or intend to use a ginseng-containing product during the study;
- •9.Those who are current users of monoamine oxidase inhibitor (MAOI) antidepressants, anticoagulants and anti-hyperglycaemic medications;
- •10.Individuals having pulmonary rehabilitation within three months of the commencement of the study, or intend to enter pulmonary rehabilitation during the study.
Investigators
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