PMSNCT05145257

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

A study testing Elix Cycle Balance in people with PMS and Menstrual Pain, run by Zenchi, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 36 years, women onlyHealthy volunteers can take part
Conditions the study is for: PMS, Menstrual Pain
What is being tested?: Elix Cycle Balance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2022to 31 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 36 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 16Show fewer

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)

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Citruslabs
Santa Monica, California, 90404

Other trials in United States

About this study

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
Being tested: Elix Cycle Balance
Medical subject headings: Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elix Cycle BalanceDietary 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

Study groups in NCT05145257
Study group	Role	What they receive
Elix Cycle Balance	Other	Elix Cycle Balance supplement Receives: Dietary Supplement: Elix Cycle Balance

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 1, Month 2, Month 3

Secondary outcomes (13)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 1, Month 2, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 202231 May 2022

First posted6 Dec 2021
Study start5 Jan 2022
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PMSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05145257
Sponsor's protocol ID: 20239Elix
Status last verified: Dec 2024
First submitted: 23 Nov 2021
Last updated: 1 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
ClinicalTrials.gov ID: NCT05145257
Acronym / sponsor ID: 20239Elix
Conditions: PMS, Menstrual Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Zenchi, Inc.Industry (pharma, biotech, devices)
Collaborators: Citruslabs
Study start: 5 Jan 2022 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 6 Dec 2021 (actual)
Results: Posted 1 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Elix Cycle Balance	Other	Dietary Supplement: Elix Cycle BalanceElix Cycle Balance supplement

Who may qualify

Ages: 18 to 36 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Elix Cycle BalanceEach 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	Dietary supplement	Elix Cycle Balance

Primary outcome

Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]
Time frame: 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]
Time frame: 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]
Time frame: 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.

13 secondary outcomes

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

Results and safety

Results posted to the registry on 1 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elix Cycle Balance	68	61

Primary outcome: Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]

Time frame: Baseline, Month 1, Month 2, Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Elix Cycle Balance n = 61
Baseline	4.41 (1.10)
Month 1	3.48 (1.18)
Month 2	3.12 (1.14)
Month 3	2.72 (1.09)

Elix Cycle Balance: p <0.001, ANOVA

Primary outcome: Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]

Time frame: Baseline, Month 1, Month 2, Month 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Elix Cycle Balance n = 61
Baseline	5.00 (0.92)
Month 1	3.95 (1.31)
Month 2	3.30 (1.24)
Month 3	3.02 (1.30)

Elix Cycle Balance: p <0.001, ANOVA

Primary outcome: Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]

Time frame: Baseline, Month 1, Month 2, Month 3. Mean (Standard Deviation). Unit: NSAID tablets per day

Measure	Elix Cycle Balance n = 61
Baseline	2.05 (0.16)
Month 1	1.32 (0.06)
Month 2	1.07 (0.13)
Month 3	0.86 (0.03)

Elix Cycle Balance: p <0.001, ANOVA

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elix Cycle Balance	0 of 68 (0%)	7 of 68 (10.3%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susanne Mitschke, MSc principal investigator

Citruslabs

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elix Cycle Balance in people with PMS and Menstrual Pain, run by Zenchi, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months] (time frame: Baseline, Month 1, Month 2, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.