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Trial registered on ANZCTR
Registration number
ACTRN12621000228886
Ethics application status
Approved
Date submitted
1/02/2021
Date registered
4/03/2021
Date last updated
16/02/2023
Date data sharing statement initially provided
4/03/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of a novel herbal and nutritional supplement for pain management in chronic pain
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Scientific title
A randomized placebo-controlled pilot trial on palmitoylethanalomide and curcumin for pain management in patients with chronic pain
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Secondary ID [1]
303226
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Nil known
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Universal Trial Number (UTN)
U1111-1264-0539
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic non-cancer pain
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Condition category
Condition code
Neurological
318279
318279
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0
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Other neurological disorders
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Musculoskeletal
318753
318753
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Clear capsules containing Palmitoylethanolamide (150mg) an enhanced bioavailability turmeric extract (275mg), and excipients.
Dose - 2 capsules twice daily (total of 4 capsules/day)
Duration - 8 weeks
Mode of administration - oral
Intervention compliance will be assessed by counting number of returned capsules.
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Intervention code [1]
319616
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Treatment: Other
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Comparator / control treatment
Clear capsules containing microcrystalline cellulose, edible yellow pigment and excipients
Dose - 2 capsules twice daily (total of 4 capsules/day)
Duration - 8 weeks
Mode of administration - oral
Intervention compliance will be assessed by counting number of returned capsules.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Difference between treatment groups in average weekly pain intensity, measured on a visual analogue scale
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Assessment method [1]
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Timepoint [1]
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From baseline to 8 weeks post intervention commencement, assessed daily through pain management app.
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Secondary outcome [1]
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Difference between treatment groups in pain intensity - area under the curve for daily pain scores, measured on a visual analogue scale
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Assessment method [1]
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Timepoint [1]
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From baseline to 8 weeks post intervention commencement, assessed daily through pain management app.
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Secondary outcome [2]
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Difference between treatment groups on PROMIS Pain Intensity – Short Form 3a V1.0
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Assessment method [2]
391230
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Timepoint [2]
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From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
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Secondary outcome [3]
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Difference between treatment groups on PROMIS Pain Interference – Short Form 8a
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Assessment method [3]
391231
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Timepoint [3]
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From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
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Secondary outcome [4]
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Difference between treatment groups on Pain and Sleep Questionnaire
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Assessment method [4]
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Timepoint [4]
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From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
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Secondary outcome [5]
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Difference between treatment groups on Beck Depression Inventory
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Assessment method [5]
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Timepoint [5]
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From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
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Secondary outcome [6]
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Participant ratings of overall improvement - assessed by the Patient Global Impression of Change scale.
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Assessment method [6]
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Timepoint [6]
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From baseline to 8 weeks post intervention commencement, assessed at weeks four and eight.
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Secondary outcome [7]
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Difference between treatment groups on Short Form Health Survey (SF-36).
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Assessment method [7]
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Timepoint [7]
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From baseline to 8 weeks post intervention commencement, assessed at baseline and week eight.
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Secondary outcome [8]
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Clinical safety assessment through evaluation of full blood count and electrolyte/liver function tests from venous blood sample.
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Assessment method [8]
391236
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Timepoint [8]
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From baseline to 8 weeks post intervention commencement, assessed at baseline and week eight.
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Secondary outcome [9]
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Differences between treatment groups in pain medication intake.
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Assessment method [9]
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Timepoint [9]
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From baseline to 8 weeks post intervention commencement, daily medication use will be recorded through pain management app.
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Secondary outcome [10]
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Difference between treatment groups in blood pressure, assessed with a digital blood pressure cuff.
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Assessment method [10]
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Timepoint [10]
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From baseline to 8 weeks post intervention commencement, assessed at baseline, week four and week eight.
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Eligibility
Key inclusion criteria
Participants meeting the following criteria to be included in the study:
- Adults with chronic pain – defined as persistent pain for 12 weeks or more.
- Average pain score of 4 or >4 on the visual analogue scale (0-10) for related pain intensity in 3-day diary.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants meeting the following criteria to be excluded from the study:
- Diagnosed with any of the following medical conditions: neurological disease, gallstones or bile duct obstruction, cancer, currently unwell with acute infection or fever.
- Cause of chronic pain is related to a hormonal condition such as menstrual pain or endometriosis, or is autoimmune in nature.
- Currently experiencing acute pain unrelated to chronic pain.
- In poor general health or baseline blood tests shows abnormal results that require further investigation (as evaluated by PI).
- Taking any of the following medications: anti-platelet or anti-coagulant medication, steroids, turmeric or curcumin or PEA supplements, within previous four weeks.
- Taking any herbal or nutritional supplements, unless consistently taking for four weeks or more and planning to continue with them throughout the study. Patients with inconsistent use may choose to stop taking the supplements and be re-evaluated for study entry after one week.
- Pregnancy, planned pregnancy, or currently breastfeeding.
- Planned surgery within two months.
- Allergy/sensitivity to study drugs or their formulations.
- Individuals that have participated in another clinical trial in the last 30 days.
- Inability or unwillingness of subject or legally acceptable representative to give written informed consent.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be allocated to one of two treatment arms through consecutive distribution of pre-randomised coded study medication containers. Study medication containers will be identical across treatment arms with labeling coded to ensure blinding across groups.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All data will be analysed based on the intention to treat population (ITT), that is, all subjects that are randomised into the study, unless they are withdrawn before being allocated to a treatment arm (on the basis of pathology review). Missing data within the ITT analysis will be imputed based on the last observation carried forward (LOCF) method. A separate analysis will be conducted on the per-protocol population (PP) for comparison of results where the protocol has been followed for the full eight weeks.
Data will be analysed using SPSS V.27 (IBM®) software. Descriptive statistics will be presented for continuous variables as either mean (SD) or median (25th-75th percentile) as appropriate, and as frequency (percentage) for categorical variables. For continuous outcomes, pre/post comparisons will be investigated using either paired t-tests (if approximations regarding normality are satisfied) or median regression. Secondary outcomes involving multiple timepoints will be analysed using repeated measures ANOVA. Results will be considered statistically significant if p<0.05. There will be no adjustment for multiple comparisons.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/05/2021
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Actual
18/06/2021
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Date of last participant enrolment
Anticipated
31/08/2021
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Actual
15/03/2022
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Date of last data collection
Anticipated
10/05/2022
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Actual
18/05/2022
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Sample size
Target
40
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
32900
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2482 - Mullumbimby
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Recruitment postcode(s) [2]
32901
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2137 - Cabarita
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Integria Healthcare (Australia) Pty Ltd.
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Address [1]
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Building 5, 2728 Logan Road (Cnr School Rd),
Freeway Office Park, Eight Mile Plains QLD 4113
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Country [1]
307634
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Integria Healthcare (Australia) Pty Ltd.
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Address
Building 5, 2728 Logan Road (Cnr School Rd),
Freeway Office Park, Eight Mile Plains QLD 4113
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
308428
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Address [1]
308428
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Country [1]
308428
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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National Institute of Integrative Medicine
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Ethics committee address [1]
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Suite 6, Riverwalk One, 140 Robina Town Centre Dr, Robina QLD 4226
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Ethics committee country [1]
307676
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Australia
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Date submitted for ethics approval [1]
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10/11/2020
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Approval date [1]
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17/05/2021
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Ethics approval number [1]
307676
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NIIM HREC Reference number: 0081E_2020
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Summary
Brief summary
A randomized placebo-controlled pilot trial on palmitoylethanolamide (PEA) and curcumin for pain management in patients with chronic non-cancer pain. The overarching aim of this study is to evaluate the efficacy of a combined herbal/nutritional supplement for pain management and quality of life (QOL) indices for patients with chronic pain. Primary Objective • Evaluate the effect of combined PEA/curcumin capsules on pain management in patients with chronic pain in comparison to placebo. Secondary Objectives • Evaluate the effect of combined PEA/curcumin capsules on associated QOL parameters and daily functioning in patients with chronic pain in comparison to placebo. • Compare pain medication consumption between PEA/Curcumin group and placebo group • Evaluate safety of combined PEA/curcumin capsules with existing pain medication.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Stuart Glastonbury
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Address
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Tweed Coast Medical Centre
5/51 Tweed Coast Rd, Bogangar NSW 2488
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Country
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Australia
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Phone
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+61 2 66760106
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Stuart Glastonbury
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Address
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Tweed Coast Medical Centre
5/51 Tweed Coast Rd, Bogangar NSW 2488
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Country
108099
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Australia
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Phone
108099
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+61 2 66760106
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Fax
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Email
108099
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[email protected]
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Contact person for scientific queries
Name
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Stuart Glastonbury
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Address
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Tweed Coast Medical Centre
5/51 Tweed Coast Rd, Bogangar NSW 2488
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Country
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Australia
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Phone
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+61 2 66760106
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Fax
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Email
108100
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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