NCT05810116已完成4 期
Effect of Palmitoylethanolamide (PEA) Compared to a Placebo on Acute Menstrual Pain in an Adult Population - a Double-blind, Crossover, Randomised Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)
研究概览
简要总结
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Palmitoylethanolamide (PEA) compared to placebo on menstrual pain in otherwise healthy participants 18 years and over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who experience mild to moderate menstruating pain
- •Aged 18 years or over
- •History of over the counter (OTC) analgesic use for the treatment of menstrual pain
- •Self-reported history of menstrual cramp pain occurring during four of the past six menstrual cycles.
- •Typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, ibuprofen or acetaminophen taken on at least 1 day of menstrual cycle for the treatment of mild to moderate menstrual cramp, and normally experiences pain relief from these medications.
- •Otherwise healthy
- •Able to provide informed consent
- •Regular menstrual cycle (28 days ± 7 days) and period
- •Agree not to participate in any other clinical trial while enrolled in this trial
排除标准
- •Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection)
- •Any bleeding disorders, recent surgery or concurrent blood thinning treatment
- •Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder) (1)
- •Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
- •Pregnant or lactating women
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic or hypersensitive to any of the ingredients in active or placebo formula
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participated in any other clinical trial during the past 1 month
- •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.
研究组 & 干预措施
Levagen+
Active Comparator
PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.
干预措施: Levagen+ (Drug)
Microcrystalline cellulose
Placebo Comparator
PEA in capsule form - 1 capsule with water upon pain onset, followed by another capsule with water after 2 hours if pain persists.
干预措施: Microcrystalline cellulose (Drug)
结局指标
主要结局
Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)
时间窗: 4 menstrual pain events over a maximum of 16 weeks
Reduction in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS) a pain assessment tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The higher the score the worse the pain.
次要结局
- Safety of Use(From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks)
- Change in categorical pain levels via categorical pain relief scale(4 menstrual pain events over a maximum of 16 weeks)
- Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM)(4 menstrual pain events over a maximum of 16 weeks)
- Change in rescue medication use via self-report(4 menstrual pain events over a maximum of 16 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upperrespiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlledtrial.ACTRN12620000846921RDC Global Pty Ltd428
招募中
2 期
Palmitoylethanolamide for Chronic Inflammatory Pain ConditionsChronic PainNCT06273462Navy Medical Center San Diego80
已完成
3 期
comparison of two drugs for checking effectiveness for nerve related paiCTRI/2021/08/036091Dr Amlendu shekhar60
尚未招募
4 期
Comparative analysis of Dietary Supplement vs Analgesic in managing pain after wisdom tooth removalCTRI/2024/08/072195Hemang Kapoor
已完成
2 期
The Effectiveness of a Topical Palmitoylethanolamide (PEA) Formulation (Levagen+) for Reducing Symptoms of EczemaEczema, AtopicNCT05003453RDC Clinical Pty Ltd72