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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05145257

Enrollment

Registered

2021-12-06

Start date

2022-01-05

Completion date

2022-05-31

Last updated

2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Pain, PMS

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.

Interventions

DIETARY_SUPPLEMENTElix 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Masking description

Open-label observational single-group

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]	Baseline, Month 1, Month 2, Month 3	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.
Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]	Baseline, Month 1, Month 2, Month 3	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.
Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]	Baseline, Month 1, Month 2, Month 3	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.

Secondary

Measure	Time frame	Description
Relief From Headaches. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Backaches. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Body Aches. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Bloating. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Reduction in Mood Swings. [Time Frame: Baseline to Week 12]	Baseline, Month 1, Month 2, Month 3	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.
Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.
Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]	Baseline, Month 1, Month 2, 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.

Countries

United States

Participant flow

Recruitment details

Main recruitment took place between 1/5/2022 - 1/10/2022 when 65 participants were recruited. A further 3 participants were recruited on 01/26/2022.

Participants by arm

Arm	Count
Elix Cycle Balance Elix Cycle Balance 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	68
Total	68

Baseline characteristics

Characteristic	Elix Cycle Balance	—
Age, Continuous	31 years STANDARD_DEVIATION 5.07	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	68 Participants	—
Sex: Female, Male Male	0 Participants	—
Survey-based assessment (0-5 scale) of menstrual symptoms	4.07 units on a scale STANDARD_DEVIATION 0.49	—
Use of over-the-counter NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms.	2.17 Number of painkillers taken per day STANDARD_DEVIATION 0.16	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 68
other Total, other adverse events	7 / 68
serious Total, serious adverse events	0 / 68

Outcome results

Primary

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.