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

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: Completed
• Conditions: Mood Change; PMS; Menstrual Cramp
• Intervention / Treatment: Dietary supplement: PMS Capsule; Dietary supplement: Capsule Placebo; Dietary supplement: PMS Gummy; Dietary supplement: Gummy Placebo

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Premenstrual Syndrome (PMS) Symptom Severity	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

Outcome Measure	Measure Description	Time Frame
Participant Perception of PMS Symptom Relief	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

• Sponsor: Semaine Health
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; Bloating; Headaches/migraines; Constipation or diarrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Premenstrual Syndrome
• Other Study ID 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