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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory - Chronic obstructive pulmonary disease; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12613000382774
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified