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Trial registered on ANZCTR


Registration number
ACTRN12614000029695
Ethics application status
Approved
Date submitted
9/01/2014
Date registered
9/01/2014
Date last updated
14/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study of Panax ginseng therapy for moderate to very severe chronic obstructive pulmonary disease
Scientific title
A randomised controlled feasibility study of Panax ginseng therapy versus placebo on the rate of exacerbation in moderate to very severe chronic obstructive pulmonary disease
Secondary ID [1] 283880 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 290865 0
Condition category
Condition code
Respiratory 291223 291223 0 0
Chronic obstructive pulmonary disease
Alternative and Complementary Medicine 291225 291225 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Panax ginseng extract, G115, in capsule form, 200 mg per day for 4 weeks. The participants will be asked to complete a daily diary to note down when they take the study medications. Drug tablet return will also be checked at every visit to improve adherence.
Intervention code [1] 288554 0
Treatment: Drugs
Comparator / control treatment
Oral lactose based Placebo 20200 mg per day for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 291217 0
Rate of exacerbation
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
Timepoint [1] 291217 0
10 weeks
Secondary outcome [1] 306248 0
St Georges Respiratory Questionnaire (SGRQ)
Timepoint [1] 306248 0
10 weeks
Secondary outcome [2] 306250 0
COPD Assessment Test (CAT)
Timepoint [2] 306250 0
10 weeks
Secondary outcome [3] 306251 0
Short-form Health survey (SF-36)
Timepoint [3] 306251 0
10 weeks
Secondary outcome [4] 306252 0
6-minute walking test (6MWT)
Timepoint [4] 306252 0
10 weeks

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelopes containing a number concealed to the treatment allocation was used to randomly assign subjects. Medications, in packages concealed to the randomisation code were dispensed from the hospitals central pharmacy by blinded pharmacists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation list was supplied by an independent bio statistician.
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
Efficacy
Statistical methods / analysis
Analysis of all outcomes will be by t-test at the end of each time point. Data will be evaluated with an intention-to-treat method using Last Observation Carried Forward (LOCF). A sample size calculation was not performed as this is a feasability to study to gauage the applicability of implmenting a larger sale trial. A sample size of 10 was selected by the investigators.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
1/08/2012
Date of last participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 5732 0
China
State/province [1] 5732 0
Guangzhou

Funding & Sponsors
Funding source category [1] 288522 0
Government body
Name [1] 288522 0
National Health and Medical Research Council (NHMRC)
Country [1] 288522 0
Australia
Funding source category [2] 288523 0
Hospital
Name [2] 288523 0
Guangdong Provincial Academy of Chinese Medical Sciences
Country [2] 288523 0
China
Primary sponsor type
University
Name
RMIT University
Address
PO Box 71, Bundoora, Victoria, 3083 Australia
Country
Australia
Secondary sponsor category [1] 287232 0
Hospital
Name [1] 287232 0
Guangdong Provincial Academy of Chinese Medical Sciences
Address [1] 287232 0
111 Dade Rd, Guangzhou, Guangdong, China
Country [1] 287232 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290385 0
Guangdong Provincial Hospital Human Ethics Committee
Ethics committee address [1] 290385 0
Ethics committee country [1] 290385 0
China
Date submitted for ethics approval [1] 290385 0
Approval date [1] 290385 0
06/06/2012
Ethics approval number [1] 290385 0
B2012-49-01

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

Contacts
Principal investigator
Name 45430 0
Prof Charlie Xue
Address 45430 0
RMIT University, PO BOX 71, Bundoora, 3083 VIC
Country 45430 0
Australia
Phone 45430 0
+61 3 9925 7360
Fax 45430 0
Email 45430 0
charlie.xue@rmit.edu.au
Contact person for public queries
Name 45431 0
Johannah Shergis
Address 45431 0
RMIT University, PO BOX 71, Bundoora, 3083 VIC
Country 45431 0
Australia
Phone 45431 0
+61 3 9925 6527
Fax 45431 0
Email 45431 0
johannah.shergis@rmit.edu.au
Contact person for scientific queries
Name 45432 0
Johannah Shergis
Address 45432 0
RMIT University, PO BOX 71, Bundoora, 3083 VIC
Country 45432 0
Australia
Phone 45432 0
+61 3 9925 6527
Fax 45432 0
Email 45432 0
johannah.shergis@rmit.edu.au

No information has been provided regarding IPD availability


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
No additional documents have been identified.