Clinical trial NCT05145257: Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
Official title: Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PMS
Menstrual Pain
Lead sponsor: Zenchi, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2021-12-06
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms.

It is hypothesized that the dietary supplement marketed as "Elix Cycle Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as cramps, bloating, and mood swings.

A total of 65 participants will be recruited for the trial following screening, with the expectation that at least 50 participants will complete the trial. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. The total intervention study period will be 3 months.


Eligibility criteria: Inclusion Criteria:

* Female aged 18-36
* Self-reported moderate to severe discomfort during menstruation, related to pelvic cramps, bloating, mood swings, or fatigue
* May experience regular or irregular menstrual cycle
* May be on birth control
* Must know or can estimate the date of the next cycle/period
* May find blood clots in menstrual blood
* Must be in good health (doesn't report any medical conditions asked in the screening questionnaire)
* Following a stable, consistent diet regimen
* Follow a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen
* Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise)
* Follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions
* Willingness to adhere to the dietary supplement regimen
* Willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period
* Is able to communicate in English
* Is willing and able to share feedback via the used technology portal
* Must provide written informed consent (ICF)

Exclusion Criteria:

* Don't experience a menstrual cycle
* Can't estimate the onset of their next menstrual cycle
* Don't experience menstrual cramping
* Follow an extreme diet intervention
* Experienced severe weight loss in the past 3 months prior to study participation
* Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle
* If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
* Food intolerances/allergies that require an EpiPen
* Known allergic reaction to any of the test product ingredients
* Currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
* Previous users of Elix Cycle Balance
* Having more than 3 alcoholic drinks a day
* Have been diagnosed with the following conditions: PCOS, Endometriosis, PMDD, Adenomyosis, Hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder
* Smokers
* Not been on a stable dose of birth control for the past 6 months

Primary outcomes:
measure: Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]
timeFrame: Baseline, Month 1, Month 2, Month 3
Secondary outcomes:
measure: Reduction in Mood Swings. [Time Frame: Baseline to Week 12]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Headaches. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Backaches. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Body Aches. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Bloating. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]
timeFrame: Baseline, Month 1, Month 2, Month 3
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke, MSc
role: PRINCIPAL_INVESTIGATOR
References: