A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement o… (NCT06763809) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
United States176 participantsStarted 2024-09-04
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 taki…
What they're measuring
1
Change in Premenstrual Syndrome (PMS) Symptom Severity
Timeframe: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)