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Trial registered on ANZCTR


Registration number
ACTRN12613000382774
Ethics application status
Approved
Date submitted
5/04/2013
Date registered
10/04/2013
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Date results information initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ginseng extract for patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
The effect of a standardised ginseng extract in patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD): a randomised, double-blind, placebo controlled trial
Secondary ID [1] 282238 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 288755 0
Condition category
Condition code
Respiratory 289113 289113 0 0
Chronic obstructive pulmonary disease
Alternative and Complementary Medicine 289134 289134 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286848 0
Other interventions
Comparator / control treatment
Matching placebo capsules (Ginsana SA, Boehringer Ingelheim Group Company) will be used. Placebo capsules will appear identical to the G115 capsules. After the run-in period, subjects will be randomised to receive 24 weeks of treatment with placebo capsules (400 mg/day), which will be supplied in 12 week packs, providing enough medication to last between visits. Placebo 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.

Ingredients of the placebo capsules are : Lactose, Silicon dioxide, Lecithin, Soya lecithin, Wax mixture, Rapeseed oil, Ethyl vanillin, Gelatine, Glycerol 85%, Iron oxide black, Iron oxide red, Dried substance from Anidrisorb 85/70 (85% solution), soya-bean oil, soya oil.
Control group
Placebo

Outcomes
Primary outcome [1] 289249 0
Exacerbation rate over 1 year recorded in participant diaries
Timepoint [1] 289249 0
Reported throughout the trial (52 weeks) duration
Secondary outcome [1] 302099 0
St George’s Respiratory Questionnaire (SGRQ)
Timepoint [1] 302099 0
baseline (week 0), week 4, week 16, week 28, week 40, week 52
Secondary outcome [2] 302100 0
COPD Assessment Test (CAT)
Timepoint [2] 302100 0
baseline (week 0), week 4, week 16, week 28, week 40, week 52
Secondary outcome [3] 302101 0
Short Form Quality of Life Questionnaire (SF-36)
Timepoint [3] 302101 0
week 4, week 28, week 52
Secondary outcome [4] 302102 0
Lung function assessed by: FEV1, FVC and the FEV1/ FVC ratio
Timepoint [4] 302102 0
baseline (week 0), week 4, week 16, week 28, week 40, week 52
Secondary outcome [5] 302103 0
Six minute walk test (6MWT)
Timepoint [5] 302103 0
baseline (week 0), week 4, week 16, week 28, week 40, week 52
Secondary outcome [6] 302104 0
Use of short-acting bronchodilator the relief medications (Ventolin) recorded in participant diaries
Timepoint [6] 302104 0
week 4, week 16, week 28, week 40, week 52
Secondary outcome [7] 302105 0
Emergency department presentations and medical practitioners visits recorded in participant diaries
Timepoint [7] 302105 0
week 4, week 16, week 28, week 40, week 52
Secondary outcome [8] 302106 0
Blood biochemistry for liver and kidney functions, and full blood examination at the Biochemistry Laboratory at Guangdong Provincial Hospital of Chinese Medicine
Timepoint [8] 302106 0
baseline (week 0) and week 28
Secondary outcome [9] 302107 0
Adverse events :any undesirable symptom or sign including abnormal laboratory results will be recorded, noting type of event, duration and intensity.
Timepoint [9] 302107 0
Reported throughout the trial (52 weeks) duration

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The results of the treatment allocation will be entered into sequentially numbered, opaque sealed envelopes. The subject draws an envelope immediately before commencement of treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All eligible subjects will be randomised using block randomisation sequences generated by a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The sample size calculation is based on the effect size reported in a multi-centre trial in China (Zheng et al,2008). For the proposed study, to achieve 30% difference between the ginseng extract and placebo treatment groups with an 80% power and a two-tailed significance level of 5%, it is estimated that a sample size of 100 subjects per group will be required, that is, 200 in total.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4976 0
China
State/province [1] 4976 0
Guangdong Province

Funding & Sponsors
Funding source category [1] 287020 0
University
Name [1] 287020 0
RMIT University
Address [1] 287020 0
PO Box 71, Bundoora
VIC, 3083
Country [1] 287020 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
PO Box 71, Bundoora
VIC, 3083
Country
Australia
Secondary sponsor category [1] 285803 0
Hospital
Name [1] 285803 0
Guangdong Provincial Hospital of Chinese Medicine
Address [1] 285803 0
No. 111 Da De Road
Guangzhou, Guangdong Province
510120
Country [1] 285803 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289059 0
Human Research and Ethics Committees of Guangdong Provincial Hospital of Chinese Medicine
Ethics committee address [1] 289059 0
No. 111 Da De Road,
Guangzhou, Guangdong Province
510120
Ethics committee country [1] 289059 0
China
Date submitted for ethics approval [1] 289059 0
Approval date [1] 289059 0
13/06/2012
Ethics approval number [1] 289059 0
B2012-49-01

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38966 0
Prof Charlie Xue
Address 38966 0
School of Health Sciences, RMIT University PO BOX 71 Bundoora VIC 3083
Country 38966 0
Australia
Phone 38966 0
+61 3 9925 7360
Fax 38966 0
Email 38966 0
charlie.xue@rmit.edu.au
Contact person for public queries
Name 38967 0
Prof Charlie Xue
Address 38967 0
School of Health Sciences, RMIT University PO BOX 71 Bundoora VIC 3083
Country 38967 0
Australia
Phone 38967 0
+61 3 9925 7360
Fax 38967 0
Email 38967 0
charlie.xue@rmit.edu.au
Contact person for scientific queries
Name 38968 0
Prof Charlie Xue
Address 38968 0
School of Health Sciences, RMIT University PO BOX 71 Bundoora VIC 3083
Country 38968 0
Australia
Phone 38968 0
+61 3 9925 7360
Fax 38968 0
Email 38968 0
charlie.xue@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Baseline characteristics were balanced between groups. The rate of COPD exacerbations was not statistically significant between groups after 1-year (62 patients in the ginseng group and 63 in the placebo group). Secondary outcome measures showed improvements after ginseng and placebo but results were not clinically significant. The incidence of adverse events in the two groups was similar and events were unrelated to the intervention.