None listed
Conditions
Brief summary
The study is a multi centre double blind, randomised, placebo controlled parallel design. There will be three arms - placebo, sea cucumber extract and sea cucumber extract plus Boswellia serrata. Three comparisons can be undertaken from this design - 1. sea cucumber extract alone versus placebo 2. the combination of sea cucumber extract with Boswellia serrata extract versus placebo 3. sea cucumber extract alone versus the combination of sea cucumber extract with Boswellia serrata extract.A sample size calculation, setting a and b at 0.05 and 0.8 respectively, was undertaken based on the variability of FEV1 in men (mean 3.5, SD 1.5) and setting d at 15% (0.7L) required 60 subjects in each arm. The study will aim to recruit 72 subjects in each arm. Total 216 subjects. Allowing for up to 15% drop-out should secure a minimum of 60 subjects in each arm.Randomisation and BlindingSubjects will be randomly allocated to one of the two treatments or placebo. Study subjects and investigators will not know the treatment assignment. Use of the double blind design will prevent ascertainment bias. The placebo will be identical in size, shape, colour and weight to the active counterparts. Both preparations will be odourless.Study SitesThe study will be carried out in four centres Lismore, Ballina, Casino and Brisbane. In Lismore the study will be based at the Teaching Clinic of the School of Natural and Complementary Medicine. The study will be based at local council facilities in Ballina and Casino. In Brisbane the study will be conducted at Greenslopes Private Hospital using the University of Queensland Department of Surgery clinic facilities. In NSW Lismore is the largest population centre and it is therefore considered that Lismore is likely to be the largest contributing centre to the study. Lismore will have four clinics per week on Monday, Tuesday, Wednesday and Thursday, Ballina two clinics on Monday and Wednesday, Casino two clinics on Tuesday and Thursday. Clinics will be held between 4pm and 8pm. In Brisbane, clinics will be held on Monday and Thursday between 4pm and 9pm.Safety MonitoringA full blood count, liver function test; and urea, creatinine and electrolytes will be taken at the start of the study, the mid-point of the study (week 8) and at the end of the study. At each follow up visit subjects will be carefully assessed for adverse events ie any new complaint or symptom that emerges during treatment with the study medication or any new complaint or pre-existing symptom that increases in frequency and/or intensity during treatment with the study medication.
Interventions
These studies will facilitate 3 sets of comparisons:
* Faulding's sea cucumber extract alone versus placebo
* the combination of Faulding's sea cucmber extract with Boswellia serrata versus placebo
* the combination of Faulding's sea cucumber extract with Boswellia serrata versus sea cucumber extract alone.
Sponsors
Fauldings Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Greater than or equal to 10% improvement in FEV1 after administration of 200mcg inhaled salbutamol sulphate (=2 puffs) NOT less than 6 hours after previous use of inhaled salbutamol sulphate; non-smoking; FEV1 greater than 60% of the predicted value for age and sex; subjects who have given their informed written consent; subjects who have at least one asthma symptom (cough or wheeze) per week; subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.
Exclusion criteria
Severe asthma as defined by the National Asthma Campaign (1998) -refer to attached handbook; any other clinically significant respiratory disease; a history of acute upper or lower respiratory tract infection within 4 weeks of starting the study; a history of oral or inhaled steroid use or leukotriene receptor antagonists within 3 months of starting the study; female subjects who are pregnant or lactating; subjects with contra-indications to the study medications; any clinically significant abnormality or disease associated with significant respiratory morbidity; subjects with any condition that, in the opinion of the investigator could be detrimental to the health of the subjects or might interfere with the evaluation of the study objective.
Outcome results
None listed