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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05145257
Recruitment Status : Completed
First Posted : December 6, 2021
Last Update Posted : June 21, 2022
Information provided by (Responsible Party):
Zenchi, Inc.

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.

Condition or disease Intervention/treatment Phase
PMS Menstrual Pain Dietary Supplement: Elix Cycle Balance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open-label observational single-group
Primary Purpose: Other
Official Title: Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
Actual Study Start Date : March 5, 2022
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Relief from menstrual symptoms and accompanying symptoms such as fatigue and mood swings. [Time Frame: Baseline to 12 weeks] [ Time Frame: 12 weeks ]
    Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings.

  2. Reduction in usage of OTC NSAIDS in the treatment of primary dysmenorrhea symptoms. [ Time Frame: 12 weeks ]
    Survey-based assessment (0-5 scale) to assess the change in number of OTC NSAIDS usage from baseline to 12 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05145257

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United States, California
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Zenchi, Inc.
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Principal Investigator: Susanne Mitschke, MSc Citruslabs
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Responsible Party: Zenchi, Inc.
ClinicalTrials.gov Identifier: NCT05145257    
Other Study ID Numbers: 20239Elix
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations