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

Phase 2

Completed

• Conditions: Respiratory - Chronic obstructive pulmonary disease; Alternative and Complementary Medicine - Herbal remedies; Chronic obstructive pulmonary disease

• Registration Number: ACTRN12614000029695
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of exacerbation<br>This will be assessed as the unmber of exacerbations based on on the pre defined definition. That is, change in baseline dyspnoea, cough and/or sputum, specifically two or more symptoms such as worsening dyspnoea, increase sputum purulence, volume or both, or any single major symptom plus more than one minor symptom including upper airway infection, unexpected fever, or increased wheezing that lasts 2 or more days[10 weeks]

Secondary Outcome Measures

Name	Time	Method
St Georges Respiratory Questionnaire (SGRQ)[10 weeks];COPD Assessment Test (CAT)[10 weeks];Short-form Health survey (SF-36) [10 weeks];6-minute walking test (6MWT)[10 weeks]