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

NCT06763809 | Completed

• 1 other identifier: 20670
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PMS; Menstrual Cramp; Mood Change

Keywords

Fatigue; Bloating; Headaches/migraines; Constipation or diarrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant Perception of PMS Symptom Relief

  From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)

Study Arms (4)

PMS Capsule Group

EXPERIMENTAL

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

Capsule Placebo Group

PLACEBO COMPARATOR

Participants in this arm will take a placebo capsule, containing microcrystalline cellulose and other inert ingredients.

Dietary Supplement: Capsule Placebo

PMS Gummy Group

EXPERIMENTAL

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

Gummy Placebo Group

PLACEBO COMPARATOR

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

Interventions

PMS Capsule DIETARY_SUPPLEMENT

Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.

PMS Capsule Group

Capsule Placebo DIETARY_SUPPLEMENT

Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.

Capsule Placebo Group

PMS Gummy DIETARY_SUPPLEMENT

Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.

PMS Gummy Group

Gummy Placebo DIETARY_SUPPLEMENT

Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside.

Gummy Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semaine Health: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

Dysmenorrhea; Fatigue; Headache; Migraine Disorders; Constipation; Diarrhea

Interventions

Spectrometry, Fluorescence

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: September 4, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)