Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Pain; PMS
• Intervention / Treatment: Dietary supplement: Elix Cycle Balance

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Elix Cycle Balance; Elix Cycle Balance supplement	Dietary supplement: Elix Cycle Balance; Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]	Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]	Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]	Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome.	Baseline, Month 1, Month 2, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Mood Swings. [Time Frame: Baseline to Week 12]	Survey-based assessment (0-5 scale) of changes in mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in anxiety and depression. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in acne flare ups. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Headaches. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in headaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Backaches. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in backaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Body Aches. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in body aches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Bloating. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in bloating. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in gastrointestinal issues. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in joint or muscle pain. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in tiredness and fatigue. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in breast tenderness. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3
Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]	Survey-based assessment (0-5 scale) of changes in appetite and food cravings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.	Baseline, Month 1, Month 2, Month 3

Collaborators and Investigators

• Sponsor: Zenchi, Inc.
• Collaborators: Citruslabs
• Investigators: Principal Investigator: Susanne Mitschke, MSc, Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea
• Other Study ID Numbers: 20239Elix

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No