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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000768099

Acronym

Ginseng Extract And Respiratory Symptoms (GEARS)

Enrollment

168

Registered

2010-09-15

Start date

2010-12-13

Completion date

2016-07-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Oral Ginseng extract capsules. 100mg/twice a day for a total of 24 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Outcome results