Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial.

Phase 3

Completed

• Conditions: Menstrual Pain; Reproductive Health and Childbirth - Menstruation and menopause; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12621000015842
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-12
• Study Completion: 2022-01-23
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

Women who experience mild to moderate menstruating pain
- Aged 18-50 years old
- Otherwise healthy
- Able to provide informed consent
- Regular menstrual cycle (28 days ± 7 days) and period

Exclusion Criteria

- Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection)
- Under or overweight (BMI <18.5 or >35kg/m2)
- Any bleeding disorders, recent surgery or concurrent blood thinning treatment
- Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, lung conditions, chronic asthma, diagnosed psychological or mood disorder)*
- Has or is currently suffering from any form of chronic disease in the past 6 months
- Use of any long-term medication that is related to dysmenorrhea or general pain
- Malignancy or treatment for malignancy within the previous 2 years
- Pregnant or lactating women
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Chronic smokers
- Allergic or hypersensitive to any of the ingredients in active or placebo formula

*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