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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
Scientific title
A randomized placebo-controlled pilot trial on palmitoylethanalomide and curcumin for pain management in patients with chronic pain
Secondary ID [1] 303226 0
Nil known
Universal Trial Number (UTN)
U1111-1264-0539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic non-cancer pain 320377 0
Condition category
Condition code
Neurological 318279 318279 0 0
Other neurological disorders
Musculoskeletal 318753 318753 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 319616 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 326373 0
Difference between treatment groups in average weekly pain intensity, measured on a visual analogue scale
Timepoint [1] 326373 0
From baseline to 8 weeks post intervention commencement, assessed daily through pain management app.
Secondary outcome [1] 391229 0
Difference between treatment groups in pain intensity - area under the curve for daily pain scores, measured on a visual analogue scale
Timepoint [1] 391229 0
From baseline to 8 weeks post intervention commencement, assessed daily through pain management app.
Secondary outcome [2] 391230 0
Difference between treatment groups on PROMIS Pain Intensity – Short Form 3a V1.0
Timepoint [2] 391230 0
From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
Secondary outcome [3] 391231 0
Difference between treatment groups on PROMIS Pain Interference – Short Form 8a
Timepoint [3] 391231 0
From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
Secondary outcome [4] 391232 0
Difference between treatment groups on Pain and Sleep Questionnaire
Timepoint [4] 391232 0
From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
Secondary outcome [5] 391233 0
Difference between treatment groups on Beck Depression Inventory
Timepoint [5] 391233 0
From baseline to 8 weeks post intervention commencement, measured as mean change in repeated measures analysis at weeks zero, two, four, six and eight.
Secondary outcome [6] 391234 0
Participant ratings of overall improvement - assessed by the Patient Global Impression of Change scale.
Timepoint [6] 391234 0
From baseline to 8 weeks post intervention commencement, assessed at weeks four and eight.
Secondary outcome [7] 391235 0
Difference between treatment groups on Short Form Health Survey (SF-36).
Timepoint [7] 391235 0
From baseline to 8 weeks post intervention commencement, assessed at baseline and week eight.
Secondary outcome [8] 391236 0
Clinical safety assessment through evaluation of full blood count and electrolyte/liver function tests from venous blood sample.
Timepoint [8] 391236 0
From baseline to 8 weeks post intervention commencement, assessed at baseline and week eight.
Secondary outcome [9] 392400 0
Differences between treatment groups in pain medication intake.
Timepoint [9] 392400 0
From baseline to 8 weeks post intervention commencement, daily medication use will be recorded through pain management app.
Secondary outcome [10] 392401 0
Difference between treatment groups in blood pressure, assessed with a digital blood pressure cuff.
Timepoint [10] 392401 0
From baseline to 8 weeks post intervention commencement, assessed at baseline, week four and week eight.

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
18/06/2021
Date of last participant enrolment
Anticipated
31/08/2021
Actual
15/03/2022
Date of last data collection
Anticipated
10/05/2022
Actual
18/05/2022
Sample size
Target
40
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32900 0
2482 - Mullumbimby
Recruitment postcode(s) [2] 32901 0
2137 - Cabarita

Funding & Sponsors
Funding source category [1] 307634 0
Commercial sector/Industry
Name [1] 307634 0
Integria Healthcare (Australia) Pty Ltd.
Country [1] 307634 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria Healthcare (Australia) Pty Ltd.
Address
Building 5, 2728 Logan Road (Cnr School Rd),
Freeway Office Park, Eight Mile Plains QLD 4113
Country
Australia
Secondary sponsor category [1] 308428 0
None
Name [1] 308428 0
Address [1] 308428 0
Country [1] 308428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307676 0
National Institute of Integrative Medicine
Ethics committee address [1] 307676 0
Ethics committee country [1] 307676 0
Australia
Date submitted for ethics approval [1] 307676 0
10/11/2020
Approval date [1] 307676 0
17/05/2021
Ethics approval number [1] 307676 0
NIIM HREC Reference number: 0081E_2020

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

Contacts
Principal investigator
Name 108098 0
Dr Stuart Glastonbury
Address 108098 0
Tweed Coast Medical Centre
5/51 Tweed Coast Rd, Bogangar NSW 2488
Country 108098 0
Australia
Phone 108098 0
+61 2 66760106
Fax 108098 0
Email 108098 0
stuartglastonbury.md@gmail.com
Contact person for public queries
Name 108099 0
Stuart Glastonbury
Address 108099 0
Tweed Coast Medical Centre
5/51 Tweed Coast Rd, Bogangar NSW 2488
Country 108099 0
Australia
Phone 108099 0
+61 2 66760106
Fax 108099 0
Email 108099 0
stuartglastonbury.md@gmail.com
Contact person for scientific queries
Name 108100 0
Stuart Glastonbury
Address 108100 0
Tweed Coast Medical Centre
5/51 Tweed Coast Rd, Bogangar NSW 2488
Country 108100 0
Australia
Phone 108100 0
+61 2 66760106
Fax 108100 0
Email 108100 0
stuartglastonbury.md@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.