Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000768099
Ethics application status
Approved
Date submitted
10/09/2010
Date registered
15/09/2010
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ginseng extract for patients with moderate Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
The effect of a standardised ginseng extract on the quality of life and respiratory symptoms of patients with moderate chronic obstructive pulmonary disease: a multi-centre, randomised, double-blind, placebo controlled trial
Secondary ID [1] 252693 0
Nil
Universal Trial Number (UTN)
Trial acronym
Ginseng Extract And Respiratory Symptoms (GEARS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 257419 0
Condition category
Condition code
Respiratory 257568 257568 0 0
Chronic obstructive pulmonary disease
Alternative and Complementary Medicine 258354 258354 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Ginseng extract capsules. 100mg/twice a day for a total of 24 weeks.
Intervention code [1] 256523 0
Treatment: Drugs
Comparator / control treatment
Oral placebo capsules. 100mg/twice a day for a total of 24 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 258486 0
Short Form Quality of Life Questionnaire (SF-36)
Timepoint [1] 258486 0
6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52
Primary outcome [2] 258487 0
COPD Assessment Test (CAT)
Timepoint [2] 258487 0
6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52
Primary outcome [3] 258485 0
St Georges Respiratory Questionnaire (SGRQ)
Timepoint [3] 258485 0
6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52
Secondary outcome [1] 264311 0
Frequency, nature and severity of exacerbations, recorded by clinical assesments.
Timepoint [1] 264311 0
5 times; week 4, week 16, week 28, week 40, week 52
Secondary outcome [2] 264275 0
Blood biochemistry for liver and kidney functions and full blood examination
Timepoint [2] 264275 0
2 times; baseline (week 0) and week 28
Secondary outcome [3] 264312 0
Relief Medication Usage (Ventolin) recorded in patient diaries.
Timepoint [3] 264312 0
5 times; week 4, week 16, week 28, week 40, week 52
Secondary outcome [4] 264274 0
Spirometry: Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
Timepoint [4] 264274 0
6 times; baseline (week 0), week 4, week 16, week 28, week 40, week 52
Secondary outcome [5] 264310 0
Adverse Events: any undesirable symptom or sign including abnormal laboratory results will be recorded, noting type of event, duration and intensity.
Timepoint [5] 264310 0
Reported throughout the trial (52 weeks) duration
Secondary outcome [6] 264313 0
Medical Resource Utilisation reported through patient and local physician inquiry.
Timepoint [6] 264313 0
5 times; week 4, week 16, week 28, week 40, week 52

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation will be entered into sequentially numbered, opaque sealed envelopes. Eligible subjects will draw an envelope 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 and stratified by site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2010
Actual
13/12/2010
Date of last participant enrolment
Anticipated
Actual
1/07/2016
Date of last data collection
Anticipated
1/07/2017
Actual
1/12/2017
Sample size
Target
168
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 2901 0
3084

Funding & Sponsors
Funding source category [1] 257636 0
Other Collaborative groups
Name [1] 257636 0
National Institute of Complementary Medicine (NICM)
Country [1] 257636 0
Australia
Funding source category [2] 257034 0
Government body
Name [2] 257034 0
National Health and Medical Research Council (NHMRC)
Country [2] 257034 0
Australia
Primary sponsor type
University
Name
Royal Melbourne Institute of Technology (RMIT) University
Address
PO Box 71, Bundoora
VIC, 3083
Country
Australia
Secondary sponsor category [1] 256292 0
Hospital
Name [1] 256292 0
Austin Health
Address [1] 256292 0
145 Studley Road
PO Box 5555
Heidelberg
Victoria
Australia 3084
Country [1] 256292 0
Australia
Secondary sponsor category [2] 256858 0
Hospital
Name [2] 256858 0
Eastern Health
Address [2] 256858 0
5 Arnold Street
Box Hill
VIC 3128
Country [2] 256858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259650 0
Eastern Health Research & Ethics Committee
Ethics committee address [1] 259650 0
Ethics committee country [1] 259650 0
Australia
Date submitted for ethics approval [1] 259650 0
Approval date [1] 259650 0
12/08/2010
Ethics approval number [1] 259650 0
E90/0910
Ethics committee name [2] 259651 0
RMIT Human Research Ethics Committee (HREC)
Ethics committee address [2] 259651 0
Ethics committee country [2] 259651 0
Australia
Date submitted for ethics approval [2] 259651 0
Approval date [2] 259651 0
11/06/2010
Ethics approval number [2] 259651 0
E31/10
Ethics committee name [3] 259029 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [3] 259029 0
Ethics committee country [3] 259029 0
Australia
Date submitted for ethics approval [3] 259029 0
Approval date [3] 259029 0
10/05/2010
Ethics approval number [3] 259029 0
HREC/10/Austin/8

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31196 0
Prof Charlie Xue
Address 31196 0
RMIT University
PO BOX 71
Bundoora
VIC 3073
Country 31196 0
Australia
Phone 31196 0
+61399257360
Fax 31196 0
Email 31196 0
charlie.xue@rmit.edu.au
Contact person for public queries
Name 14443 0
Charlie Xue
Address 14443 0
World Health Organization (WHO) Collaborating Centre for Traditional Medicine
RMIT University
PO BOX 71
Bundoora
VIC 3083
Country 14443 0
Australia
Phone 14443 0
+61 3 9925 7745
Fax 14443 0
+61 3 9925 7178
Email 14443 0
gears@rmit.edu.au
Contact person for scientific queries
Name 5371 0
Charlie Xue
Address 5371 0
World Health Organization (WHO) Collaborating Centre for Traditional Medicine
RMIT University
PO BOX 71
Bundoora
VIC 3083
Country 5371 0
Australia
Phone 5371 0
+61 3 9925 7745
Fax 5371 0
+61 3 9925 7178
Email 5371 0
gears@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?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePanax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): Study protocol for a randomised controlled trial.2011https://dx.doi.org/10.1186/1745-6215-12-164
Embase12-month randomised controlled trial of ginseng extract for moderate COPD.2019https://dx.doi.org/10.1136/thoraxjnl-2018-212665
N.B. These documents automatically identified may not have been verified by the study sponsor.