Clinical trial NCT06763809: A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
Official title: A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PMS
Menstrual Cramp
Mood Change
Keywords: Fatigue
Bloating
Headaches/migraines
Constipation or diarrhea
Lead sponsor: Semaine Health
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2025-01-08
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Premenstrual Syndrome (PMS) Symptom Severity
timeFrame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Secondary outcomes:
measure: Participant Perception of PMS Symptom Relief
timeFrame: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Citruslabs
state: Nevada
Study officials:
References: