Clinical trial NCT06124326: A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome
Official title: A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Lead sponsor: Rael
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle. Questionnaires will be completed at the following time points:

* Baseline
* Day 7 of their first cycle during the trial (After using the product PRN during their period)
* 4 days before their second period during the trial (After using the product PRN for the previous month)
* Day 3 of their second period during the trial (After using the product for 7 days straight)
* Day 3 of their third period of the trial (After using the product for 7 days straight)


Eligibility criteria: Inclusion Criteria:

* Female, aged 18-40
* Self-reported moderate discomfort during menstruation related to pelvic cramps, bloating, fatigue, or mood swings.
* Self-reported symptoms during their menstrual cycle with gas, heartburn, and acid reflux
* Generally healthy - don't live with any uncontrolled chronic disease
* Has a menstrual cycle between 21 and 35 days in length
* Able to predict their menstrual cycle and timing of their menstruation

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Current use of any blood thinning medication
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding, or attempting to become pregnant
* Unwilling to follow the study protocol.
* Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system? e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
* Anyone currently on hormonal birth control, or has been on hormonal birth control in the last 3 months

Primary outcomes:
measure: Changes in pelvic cramps.
timeFrame: Baseline to Week 12
measure: Changes in energy levels.
timeFrame: Baseline to Week 12
measure: Changes in overall mood.
timeFrame: Baseline to Week 12
measure: Changes in bloating.
timeFrame: Baseline to Week 12
measure: Changes in gastrointestinal discomfort.
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: