A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome

January 2, 2025 updated by: Semaine Health
This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female 18+ years of age.
  • Must be in good health with no significant chronic conditions (such as oncological or psychiatric disorders) and a BMI under 35.
  • Must experience at least five of the following symptoms during their menstrual cycle:

Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances

  • Must have a regular menstrual cycle with a bleed week, and must be currently tracking their menstrual cycle and able to accurately predict their bleed week.
  • If using hormonal contraception, must do so for at least three months before starting the trial, and remain consistent with taking it as per healthcare provider instructions during the study.
  • If using hormonal contraception, must allow for a bleed week every month.
  • Must agree to avoid cannabis, CBD, ashwagandha, and supplements other than multivitamins or protein powders for 24 hours prior to the study, and during the full study duration.
  • Willing to refrain from OTC pain medications or supplements to target period-related symptoms during the study period.
  • Must live in the United States.

Exclusion Criteria:

  • Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
  • Anyone currently undergoing or planning to undergo during the study period, any gynecological-related procedures.
  • Anyone diagnosed with Graves disease, Hashimotos or taking any medication for their thyroid.
  • Anyone who has undergone any surgeries or invasive treatments in the last six months, or is planning to during the study period.
  • Anyone with any allergic reactions requiring the use of an Epi-pen.
  • Anyone with known severe allergic reactions, or history of allergy or intolerance to ingredients found in over-the-counter dietary, vitamin or herbal supplements.
  • Anyone with any allergies or sensitivities to any of the study product ingredients.
  • Anyone with known allergies to nightshades (e.g., eggplant, tomato, bell pepper, potato).
  • Unwilling to follow the study protocol.
  • Anyone pregnant, breastfeeding, or trying to conceive currently or for the duration of the study.

Participants will self-report that they are not pregnant.

  • Current use of an extended activity hormonal contraception (examples include Depo-Provera injection, Nexplanon implant, or hormonal intrauterine devices (IUDs)).
  • Currently participating in any other clinical study or planning to at any point during this study's duration.
  • Anyone who has an alcohol dependency, regularly uses cannabis, or is using illicit drugs.
  • Anyone with a history of substance abuse.
  • Anyone who regularly takes supplements that might reduce inflammation or is planning to at any point during the study period.
  • Anyone currently taking prescription pain medication for any indication.
  • Anyone who is currently taking, or planning to take during the study period, any medications, supplements or products targeted at improving Premenstrual Syndrome symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PMS Capsule Group
Participants in this arm will take the PMS capsule, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Boswellia, Milk Thistle Extract, Resveratrol, and Ashwagandha.
Dietary supplement: PMS Capsule
Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
Placebo Comparator: Capsule Placebo Group
Participants in this arm will take a placebo capsule, containing microcrystalline cellulose and other inert ingredients.
Dietary supplement: Capsule Placebo
Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
Experimental: PMS Gummy Group
Participants in this arm will take the PMS gummy, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Lemon Balm Extract, Milk Thistle Extract, and Resveratrol.
Dietary supplement: PMS Gummy
Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.
Placebo Comparator: Gummy Placebo Group
Participants in this arm will take a placebo gummy, containing inert ingredients such as tapioca syrup, cane sugar, and citric acid.
Dietary supplement: Gummy Placebo
Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Premenstrual Syndrome (PMS) Symptom Severity
Time Frame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Evaluate the effectiveness of the PMS capsule and gummy in alleviating symptoms associated with PMS, using the validated Menstrual Symptom Questionnaire (MSQ). The MSQ assesses 24 symptoms with scores ranging from 1 (never) to 5 (always), where a higher score indicates greater symptom severity.
From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Perception of PMS Symptom Relief
Time Frame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Assess participants' subjective perception of symptom relief provided by the PMS capsule and gummy, using a custom survey with questions related to satisfaction, effectiveness, and tolerability.
From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Semaine Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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