Menstrual Pain Clinical Trial
Official title:
An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms
NCT number | NCT05019924 |
Other study ID # | 20216 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | November 30, 2021 |
Verified date | March 2022 |
Source | Semaine Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Citruslabs | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Semaine Health | Citruslabs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in perceived discomfort associated with menstruation [Time Frame: Baseline to 8 weeks) | Perceived discomfort caused by several of the most common menstrual symptoms Cramping Bloating Gastrointestinal issues (diarrhea or constipation) Feeling tired Feeling down emotionally Feeling anxious Headache
Each endpoint will be reported by the participant on a scale of perceived discomfort at the end of each menstrual cycle. Participants will complete the surveys for each menstrual cycle. The study uses a questionnaire including a scale from 0-7 to assess the severity of symptoms(0=no symptoms and 7=very severe symptoms). To ensure consistency between participants, each survey will be completed on days 7 or 8 after they stop hormonal contraception usage (or begin placebo pills). |
8 week intervention period | |
Secondary | Change in blood biomarkers: C-Reactive Protein (CRP) and 25-hydroxyvitamin D [Time Frame: Baseline to 8 weeks] | Change in C-Reactive Protein (CRP) and 25-hydroxyvitamin D biomarkers measured with an at-home blood test after 8 weeks compared to baseline results. | 8 week intervention period |
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