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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Obstructive Pulmonary Disease (COPD)

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Alternative and Complementary Medicine

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]

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]

Exacerbation rate over 1 year recorded in participant diaries

Timepoint [1]

Reported throughout the trial (52 weeks) duration

Secondary outcome [1]

St George’s Respiratory Questionnaire (SGRQ)

Timepoint [1]

baseline (week 0), week 4, week 16, week 28, week 40, week 52

Secondary outcome [2]

COPD Assessment Test (CAT)

Timepoint [2]

baseline (week 0), week 4, week 16, week 28, week 40, week 52

Secondary outcome [3]

Short Form Quality of Life Questionnaire (SF-36)

Timepoint [3]

week 4, week 28, week 52

Secondary outcome [4]

Lung function assessed by: FEV1, FVC and the FEV1/ FVC ratio

Timepoint [4]

baseline (week 0), week 4, week 16, week 28, week 40, week 52

Secondary outcome [5]

Six minute walk test (6MWT)

Timepoint [5]

baseline (week 0), week 4, week 16, week 28, week 40, week 52

Secondary outcome [6]

Use of short-acting bronchodilator the relief medications (Ventolin) recorded in participant diaries

Timepoint [6]

week 4, week 16, week 28, week 40, week 52

Secondary outcome [7]

Emergency department presentations and medical practitioners visits recorded in participant diaries

Timepoint [7]

week 4, week 16, week 28, week 40, week 52

Secondary outcome [8]

Blood biochemistry for liver and kidney functions, and full blood examination at the Biochemistry Laboratory at Guangdong Provincial Hospital of Chinese Medicine

Timepoint [8]

baseline (week 0) and week 28

Secondary outcome [9]

Adverse events :any undesirable symptom or sign including abnormal laboratory results will be recorded, noting type of event, duration and intensity.

Timepoint [9]

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

Sex

Both males and females

Can healthy volunteers participate?

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

10/04/2013

Actual

10/04/2013

Date of last participant enrolment

Anticipated

Actual

12/11/2014

Date of last data collection

Anticipated

Actual

12/11/2015

Sample size

Target

200

Accrual to date

Final

200

Recruitment outside Australia

Country [1]

China

State/province [1]

Guangdong Province

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University

Address [1]

PO Box 71, Bundoora
VIC, 3083

Country [1]

Australia

Primary sponsor type

University

Name

RMIT University

Address

PO Box 71, Bundoora
VIC, 3083

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Guangdong Provincial Hospital of Chinese Medicine

Address [1]

No. 111 Da De Road
Guangzhou, Guangdong Province
510120

Country [1]

China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research and Ethics Committees of Guangdong Provincial Hospital of Chinese Medicine

Ethics committee address [1]

No. 111 Da De Road, 
Guangzhou, Guangdong Province
510120

Ethics committee country [1]

China

Date submitted for ethics approval [1]

Approval date [1]

13/06/2012

Ethics approval number [1]

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

Prof Charlie Xue

Address

School of Health Sciences, RMIT University PO BOX 71 Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7360

Fax

[email protected]

Contact person for public queries

Name

Charlie Xue

Address

School of Health Sciences, RMIT University PO BOX 71 Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7360

Fax

[email protected]

Contact person for scientific queries

Name

Charlie Xue

Address

School of Health Sciences, RMIT University PO BOX 71 Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7360

Fax

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Panax ginseng therapy for chronic obstructive pulmonary disease: A clinical trial protocol and pilot study.	2014	https://dx.doi.org/10.1186/1749-8546-9-20
Embase	Effect of panax ginseng (G115) capsules versus placebo on acute exacerbations in patients with moderate to very severe copd: A randomized controlled trial.	2020	https://dx.doi.org/10.2147/COPD.S236425
Embase	Ginseng alleviates microbial infections of the respiratory tract: a review.	2020	https://dx.doi.org/10.1016/j.jgr.2019.12.001

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically