None listed
Conditions
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.
Interventions
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.
Sponsors
Integria Healthcare (Australia) Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed