None listed
Conditions
Brief summary
This study will investigate the safety profile and efficacy of a standardised extract of Panax ginseng with a focus on exacerbation rates in adults with moderate to very servere chronic obstructive pulmonary disease. The study is a 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
G115 (Ginsana SA, Boehringer Ingelheim Group company) is standardised extract of the species Panax Ginseng C. A. Meyer that contains 4% ginsenosides. G115 capsules will be provided as gel filled soft capsules for oral intake. Each capsule is 100 mg, so subjects will take 2 capsules each time, twice daily.
Eligible subjects will be randomised to receive 24 weeks of treatment with ginseng extract capsules (400 mg/day), which will be supplied in 12 week packs. Subjects will attend 2 appointments d
G115 (Ginsana SA, Boehringer Ingelheim Group company) is standardised extract of the species Panax Ginseng C. A. Meyer that contains 4% ginsenosides. G115 capsules will be provided as gel filled soft capsules for oral intake. Each capsule is 100 mg, so subjects will take 2 capsules each time, twice daily. Eligible subjects will be randomised to receive 24 weeks of treatment with ginseng extract capsules (400 mg/day), which will be supplied in 12 week packs. Subjects will attend 2 appointments during the 24 week treatment period, each visit will involve symptom assessment, collection and distribution of Participant Diaries, completion of 2 questionnaires (SGRQ and CAT), a 6MWT and lung function tests. They will receive the second pack of trial medication (12 weeks worth) and relief medication and complete a Patient Opinion of Chinese Medicine Questionnaire (mid-treatment) and Short Form 36 questionnaire (end of treatment). Blood sample will be taken at the end of treatment. There will be a followup period of 24 weeks after the treatment period.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed