Ginseng extract for patients with moderate 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: ACTRN12610000768099
• Lead Sponsor: Royal Melbourne Institute of Technology (RMIT) University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
St Georges Respiratory Questionnaire (SGRQ)[6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52];Short Form Quality of Life Questionnaire (SF-36)[6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52];COPD Assessment Test (CAT)[6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52]

Secondary Outcome Measures

Name	Time	Method
Spirometry: Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)[6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52];Blood biochemistry for liver and kidney functions and full blood examination[2 times; baseline (week 0) and week 28];Adverse Events: any undesirable symptom or sign including abnormal laboratory results will be recorded, noting type of event, duration and intensity.[Reported throughout the trial (52 weeks) duration];Frequency, nature and severity of exacerbations, recorded by clinical assesments.[5 times; week 4, week 16, week 28, week 40, week 52];Relief Medication Usage (Ventolin) recorded in patient diaries.[5 times; week 4, week 16, week 28, week 40, week 52];Medical Resource Utilisation reported through patient and local physician inquiry.[5 times; week 4, week 16, week 28, week 40, week 52]