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

Royal Melbourne Institute of Technology (RMIT) University0 个研究点目标入组 168 人开始时间: 2010年9月15日最近更新: 2020年1月13日

适应症

试验速览

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•1. Both male and female, aged 40 years and over;
•2. Smokers and ex-smokers;
•3. 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%;
•4. Are clinically stable, that is, did not experience an acute infective exacerbation of COPD from at least 4 weeks prior to trial entry;
•5. Meet the Chinese Medicine diagnostic criteria for Lung Qi deficiency or Lung & Spleen Qi deficiency;
•6. Informed written consent for participation in the study.

•1. 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.

发起方

Royal Melbourne Institute of Technology (RMIT) University