None listed
Conditions
Brief summary
This is a double-blind, randomised, clinical study with a 14-day treatment duration with 2 arms (with 2 active ingredient groups and 2 placebo groups). The aim of this study is to assess the effectiveness of PEA and curcumin on reducing joint pain in otherwise healthy adults aged 25-70 years, compared to a placebo. A placebo is a substance with no therapeutic effect, in this case maltodextrin. Participants will be asked to attend our clinic to complete their enrolment with a Trial Coordinator. During this visit, they will also complete an initial assessment including, letting the trial coordinator know about their joint pain and general health by completing questionnaires; height and weight measurements; and a blood test. At the conclusion of the visit, participants will be randomly allocated to either the PEA, curcumin or placebo treatment group. Once enrolled in the study, participants will be asked to complete 3 days of pain recording (once morning and once at night) online. Following the completion of the 3 days of pain recording, trial coordinators will confirm supplementation commencement. Capsules should be consumed as described on the label. Once supplementation has started, participants will be required to record their pain level every morning upon waking, and every night prior to going to bed for 2 weeks. At the completion of the 2 weeks, participants will be required to attend the clinic for a final appointment where they will complete identical assessments to the initial visit.
Interventions
The intervention is Palmitoylethanolamide (PEA) or Curcumin (2 arm study).
Participants will take 1 capsule containing 175 mg of PEA twice daily for 2 weeks (1 capsule in the morning and 1 capsule in the evening).
OR
One capsule containing a total 500 mg of HydroCurc taken daily in the evening before bed for 2 weeks.
Compliance will be monitored via capsule return at the end of the study.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Male and females 25-70 years old Reporting joint pain (not associated with acute injury or long-standing disease) Generally healthy Able to provide informed consent If female, must use either a prescribed form of birth control, are abstinent or post-menopausal Agree not to change current diet or exercise during the study Agree not to take any pain medication during the study
Exclusion criteria
Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)* Malignancy or treatment for malignancy within the previous 2 years Diagnosed rheumatoid arthritis, bursitis and/or gout Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy Serious mood disorders or neurological disorders such as MS Active smokers, nicotine, alcohol, drug abuse Chronic past and/or current alcohol use (more than 14 standard alcoholic drinks week) Allergic to any of the ingredients in active or placebo formula Known pregnant or lactating woman Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion Participants who have participated in any other related clinical study during the past 1 month History of infection in the month prior to the study *An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
Outcome results
None listed