search
Back to results

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

Primary Purpose

PMS, Menstrual Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elix Cycle Balance
Sponsored by
Zenchi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PMS

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Elix Cycle Balance

Arm Description

Elix Cycle Balance supplement

Outcomes

Primary Outcome Measures

Relief from menstrual symptoms and accompanying symptoms such as fatigue and mood swings. [Time Frame: Baseline to 12 weeks]
Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings.
Reduction in usage of OTC NSAIDS in the treatment of primary dysmenorrhea symptoms.
Survey-based assessment (0-5 scale) to assess the change in number of OTC NSAIDS usage from baseline to 12 weeks

Secondary Outcome Measures

Full Information

First Posted
November 23, 2021
Last Updated
June 16, 2022
Sponsor
Zenchi, Inc.
Collaborators
Citruslabs
search

1. Study Identification

Unique Protocol Identification Number
NCT05145257
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenchi, Inc.
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PMS, Menstrual Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open-label observational single-group
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elix Cycle Balance
Arm Type
Other
Arm Description
Elix Cycle Balance supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Elix Cycle Balance
Intervention Description
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 Measure Information:
Title
Relief from menstrual symptoms and accompanying symptoms such as fatigue and mood swings. [Time Frame: Baseline to 12 weeks]
Description
Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings.
Time Frame
12 weeks
Title
Reduction in usage of OTC NSAIDS in the treatment of primary dysmenorrhea symptoms.
Description
Survey-based assessment (0-5 scale) to assess the change in number of OTC NSAIDS usage from baseline to 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Mitschke, MSc
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs