A feasibility study of Panax ginseng therapy for moderate to very severe chronic obstructive pulmonary disease

A randomised controlled feasibility study of Panax ginseng therapy versus placebo on the rate of exacerbation in moderate to very severe chronic obstructive pulmonary disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000029695

Enrollment

Registered

2014-01-09

Start date

2012-08-01

Completion date

2012-10-01

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 is a feasibility study to evaluate a trial protocol for Panax ginseng versus placebo in patients with moderate to very severe chronic obstructive pulmonary disease.

Interventions

Oral Panax ginseng extract, G115, in capsule form, 200 mg per day for 4 weeks. The participants will be asked to complete a daily diary to note down when they take the study medications. Drug tablet return will also be checked at every visit to improve adherence.

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

Inclusion criteria

1. aged between 40 and 80 years 2. postbronchodilator forced expiratory volume in 1 second (FEV1) equal to 20% and less than 80% of predicted normal values and FEV1 to forced vital capacity (FVC) of less than 70% 3. clinically stable, not have experienced an acute exacerbation of COPD from at least 4 weeks prior to trial entry and not to have been hospitalised in the past 6 months with greater than or equal to 3 exacerbations 4. meet the Chinese medicine diagnostic criteria for Lung Qi deficiency with or without Spleen or Kidney Qi deficiency.

Exclusion criteria

1. history of asthma or chronic systemic infections or inflammatory conditions other than COPD that require systemic corticosteroid treatment in the last 3 months 2. pregnant, breast-feeding or intending to become pregnant during the course of the study 3. have serious illnesses such as severe heart, liver or kidney disease 4. taking long-term immunosuppressive agents or immune-stimulants; allergic history to ginseng or currently taking ginseng; users of monoamine oxidase inhibitor antidepressants, anticoagulants and/or anti-hyperglycaemic medications 5. and those who had undertaken pulmonary rehabilitation within 3 months of the commencement of the study or intend to enter pulmonary rehabilitation during the study.

Outcome results