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

NCT05145257 | Completed Results

• 1 other identifier: 20239Elix
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

PMS; Menstrual Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Reduction in Mood Swings. [Time Frame: Baseline to Week 12]

  Baseline, Month 1, Month 2, Month 3

• Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]

  Baseline, Month 1, Month 2, Month 3

• Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]

  Baseline, Month 1, Month 2, Month 3

• Relief From Headaches. [Time Frame: Baseline to Month 3]

  Baseline, Month 1, Month 2, Month 3

• Relief From Backaches. [Time Frame: Baseline to Month 3]

  Baseline, Month 1, Month 2, Month 3

Study Arms (1)

Elix Cycle Balance

OTHER

Elix Cycle Balance supplement

Dietary Supplement: Elix Cycle Balance

Interventions

Elix Cycle Balance DIETARY_SUPPLEMENT

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

Elix Cycle Balance

Eligibility Criteria

• Age: 18 Years - 36 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zenchi, Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Patrick Renner
• Organization: Citruslabs

hello@citruslabs.com

4242450284

Study Officials

• Susanne Mitschke, MSc

  Citruslabs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label observational single-group
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 6, 2021
• Study Start: January 5, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: January 1, 2025
• Results First Posted: January 1, 2025

Record last verified: 2024-12

Locations

US (1)