An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

NCT05019924 | Completed

• 1 other identifier: 20216
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Pain; Menstrual Discomfort

Keywords

PMS; Menstrual symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in blood biomarkers: C-Reactive Protein (CRP) and 25-hydroxyvitamin D [Time Frame: Baseline to 8 weeks]

  8 week intervention period

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Dietary supplement

Dietary Supplement: Semaine

Control arm

NO INTERVENTION

No intervention given

Interventions

Semaine DIETARY_SUPPLEMENT

The dietary supplement is designed, and marketed commercially to be taken in servings of two capsules per day, up to four times per day (a total of 8 capsules daily). Most consumers, however, will only take a serving three times per day, or one with each major meal (breakfast, lunch and dinner).

Intervention arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Semaine Health: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 25, 2021
• Study Start: August 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

US (1)