An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrua… (NCT05019924) | Clinical Trial Compass
CompletedNot Applicable
An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms
United States58 participantsStarted 2021-08-01
Plain-language summary
Dietary supplementation is widely used to alleviate various symptoms of PMS and menstruation such as bloating and cramping. Providing a combination of synergistic dietary supplements is hypothesized to significantly reduce self-reported PMS and menstrual discomfort when compared with a baseline without the intervention.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Female, aged 18-40
* Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
* Ability to take oral medication and be willing to adhere to the dietary supplement regimen
* Use of hormonal contraception for at least 3 months prior to screening and agreement to use such a method during study participation. Hormonal contraception must allow for pill bleeds to occur.
* Moderate self-reported discomfort during menstruation related to bloating, pelvic cramps, fatigue or mood swings. On a scale of 1-10, participants must report at least a 4 on two or more symptoms.
* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Exclusion Criteria:
* Current use of GnRH agonists and antagonists including Lupron or Orilissa
* Current use of an extended activity hormonal contraception (for example, Depo-provera or Nexplanon)
* Current use of hyperthyroid medication such as methimazole
* Current use of blood thinning medication
* Pregnancy, lactation, or attempting to become pregnant during study
* Known allergic reactions to components of the dietary supplement (sunflower oil, ashwagandha, curcumin, resveratrol, Boswellia, milk thistle, quercetin or catechins)
What they're measuring
1
Change in perceived discomfort associated with menstruation [Time Frame: Baseline to 8 weeks)