The effect of Palmitoylethanolamide (PEA) or Curcumin on Joint Health in an adult population when compared to a placebo - a randomised, double blind interventional study.

Phase 3

Recruiting

• Conditions: Joint Pain; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619001467123
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in joint pain as measured by Visual Analog Scale (VAS). [Baseline, Daily for 2 weeks ]

Secondary Outcome Measures

Name	Time	Method
Change in weight as measured by digital scales[Baseline, Day 14];Change in quality of life as measured by SF-36, POMS and GI tolerance questionnaires. [Baseline, Day 14];Composite outcome: Change in systemic inflammation as measured by TNF-a, TGF-b, IL-1B, IL-6, IL-8, IL-10, hs-CRP with analysis by serum assay. [Baseline, Day 14 ];Composite outcome: General safety markers using E/LFT panel: Albumin, alkaline phosphatase, ALT, AST, GGT, cholesterol, HLD, LDL, triglycerides, urea, creatinine, glucose and total protein. Analysis via serum assay. [Baseline, Day 14]