A double-blind, randomised, placebo-controlled study on the safety and efficacy of Palmitoylethanolamide (PEA) for the management of mild to moderate osteoarthritis symptoms.
- Conditions
- OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12615000149561
- Lead Sponsor
- Integrated Health Group Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Medically diagnosed Osteoarthritis
VAS Pain greater than 4
Not using daily prescribed Osteoarthritis medication
Males and females 40-75 years of age
BMI between 18.5 - 35
Exclusion Criteria
All other forms of arthritis and other auto-immune issues
Significant joint injury within last 6 months
Women that are pregnant or breast feeding
Uncontrolled diagnosed serious health conditions such as diabetes, high cholesterol, hypertension, osteoporosis or have digestive disease(s).
Known hypersensitivity to herbal drugs/nutritional supplement/ foods
Have started used a drug/natural therapy for Osteoarthritis within the last 30 days – Including Fish oil/ Omega 3 supplement
Receiving/ prescribed coumandin (Warfarin) or other anticoagulation therapy
Current or history of chronic alcohol and/or drug abuse
History of cerebrovascular accident, stroke, or transient ischemia.
Major depressive disorders, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Currently using other investigational product(s).
Have experienced unintended weight loss of more than 15% of body weight in last 6 months.
Active substance abuse (alcohol or drug dependency).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method