A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severityand duration of headaches in healthy participants aged 18 years and older.
- Conditions
- HeadacheAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12618000294257
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 94
Adults aged over 18
No history or evidence of clinically significant medical conditions including, but not
limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine
(including uncontrolled diabetes or thyroid disease) or haematological abnormalities
that are uncontrolled.
Participant’s full agreement and ability to consent to participation in the study
At least 2 headache episodes per month
Access to a computer or smartphone for completing online questionnaires and
events.
Use of long-term medication (unless for controlled medical
condition as above)
Malignancy or treatment for malignancy within the previous 2 years
Pregnant or lactating women
Females not taking a prescribed form of contraception (i.e. oral
contraception pill, birth control implant e.g. implanon)
Chronic past and/or current alcohol use (>14 alcoholic drinks
week)
Smokers
Allergic or hypersensitive to any of the ingredients in the active or
ibuprofen formula
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method