Premenstrual SyndromeNCT07876050
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
A study testing Kaia Relief - Cycle System (Day and Night) in people with Premenstrual Syndrome and Menstrual Discomfort, run by Vivance Group at 1 site in United States.
Trial summary
This is a single-group, open-label, decentralized clinical trial evaluating the effects of the Kaia Relief - Cycle System (a commercial dietary supplement consisting of Day and Night capsules) on premenstrual symptom severity, menstrual discomfort, and overall well-being in premenopausal women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Menstrual Discomfort, Premenstrual Symptoms
- What is being tested?
- Kaia Relief - Cycle System (Day and Night)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female sex assigned at birth and currently premenopausal.
- Aged 18 to 45 years (inclusive) at the time of informed consent.
- Regular menstrual cycles with a cycle length of 24-35 days for at least the three months prior to enrollment.
- Self-reported recurrent premenstrual symptoms (physical and/or mood) that the participant confirms resolve within a few days of menses onset, occurring in the majority of cycles over the past three months.
- Self-reported premenstrual symptoms of at least moderate severity, defined as symptoms the participant describes as bothersome enough to interfere with normal daily activities, in the majority of cycles over the past three months.
- Willing and able to take the study product every day across the two product cycles (Cycles 2 and 3) and to complete questionnaires across all three cycles.
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- Willing to maintain current diet, physical activity level, sleep routine, and stable use of any ongoing supplements for the duration of the study.
- Willing to refrain from taking any new products, medications, or supplements that target menstrual health during the study period.
- Access to a smartphone, tablet, or computer with reliable internet access to complete study assessments via the digital platform.
- Resides in the United States and willing to provide a shipping address for product delivery.
- Willing and able to provide written electronic informed consent prior to any study procedures.
Who cannot join
- Pregnant, breastfeeding, trying to conceive, or planning to become pregnant during the study period.
- Peri-menopausal or post-menopausal status (self-report or known clinical diagnosis).
- Started, stopped, or changed hormonal birth control (including oral contraceptives, hormonal IUD, patch, ring, or injectable hormonal contraceptives) within the three months prior to enrollment, or planning to change hormonal contraception during the study.
- Known allergy or sensitivity to any ingredient in the study product, including allergy to plants of the Asteraceae/Compositae family (e.g., ragweed, chrysanthemum, marigold, yarrow) or to lavender or sweet orange essential oils.
- Diagnosed reproductive condition currently under active pharmacological treatment (e.g., polycystic ovary syndrome [PCOS], endometriosis, uterine fibroids) where treatment may confound premenstrual symptom assessment.
- Diagnosed premenstrual dysphoric disorder (PMDD) currently requiring pharmacotherapy.
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- Use of SSRIs, SNRIs, or any hormonal treatment specifically prescribed or initiated for PMS or mood regulation within the three months prior to enrollment.
- Current use of hormonal contraceptives (such as the pill, patch, vaginal ring, or hormonal IUD) or any form of hormone therapy.
- Current use of dopaminergic medications (e.g., medications prescribed for Parkinson's disease, restless legs syndrome, or hyperprolactinemia), which may interact with Vitex agnus-castus.
- Current use of anticoagulant or antiplatelet medication (e.g., warfarin, heparin, clopidogrel, or prescription-dose aspirin), due to the theoretical mild antiplatelet properties of turmeric and ginger.
- Use of other dietary supplements, herbal remedies, or over-the-counter products known to influence mood, hormonal balance, water retention, or premenstrual symptoms (e.g., evening primrose oil, St.
- John's Wort, Vitex, other agnus-castus-containing products) unless used at a stable dose for at least three months prior to enrollment and the participant agrees to maintain the same routine throughout the study.
- History of serious illness, major surgery, or hospitalization within the three months prior to enrollment.
- Planned surgery, medical procedure, or significant health intervention during the study period.
- Currently enrolled in another clinical research study, or having participated in another study within the past 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Citruslabs
Las Vegas, Nevada, 89118
Patrick Renner
About this study
Official title: A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women
This is a single-group, open-label, decentralized clinical trial evaluating the effects of the Kaia Relief - Cycle System (a commercial dietary supplement consisting of Day and Night capsules) on premenstrual symptom severity, menstrual discomfort, and overall well-being in premenopausal women. Forty-five healthy premenopausal women aged 18-45 with regular menstrual cycles and self-reported recurrent premenstrual symptoms will be enrolled.
The study spans approximately 12 weeks across three consecutive menstrual cycles. Cycle 1 serves as a no-product baseline cycle during which participants complete validated questionnaires on Day 5. During Cycles 2 and 3, participants take two Day capsules each morning and two Night capsules each evening, beginning 7 days before their anticipated period and continuing through Day 2 of their cycle. Questionnaires are completed on Day 5 of each product cycle. All study activities are conducted remotely via the Citruslabs digital study platform; there are no in-person visits, blood draws, or laboratory procedures.
- Being tested
- Kaia Relief - Cycle System (Day and Night)
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaia Relief - Cycle System (Day and Night)Dietary supplement
All enrolled participants receive the Kaia Relief - Cycle System (two Day capsules each morning and two Night capsules each evening with food) beginning 7 days before their anticipated period and continuing through Day 2 of their cycle, during Cycles 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Kaia Relief - Cycle System (Day and Night) Arm | Experimental | Not described Receives: Dietary Supplement: Kaia Relief - Cycle System (Day and Night) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Premenstrual and Menstrual Discomfort Symptoms as Assessed by the Menstrual Symptom Questionnaire (MSQ)
Mean change in MSQ total score, calculated according to the Chesney \& Tasto method including applicable reverse-scoring, from Baseline (Day 5 of Cycle 1) to the end of Cycle 3 (Day 5 of Cycle 3)
Measured: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)
Change in Menstrual Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS)
Mean change in NPRS score from Baseline (Day 5 of Cycle 1) to the end of Cycle 3 (Day 5 of Cycle 3)
Measured: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)
Secondary outcomes (1)
Participant-Perceived Effects on Premenstrual Symptoms
Participants' experience of their premenstrual symptoms and satisfaction with the product, assessed via questionnaires
Measured: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivance Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876050
- Sponsor's protocol ID
- VIVAN-44115
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women
- ClinicalTrials.gov ID
- NCT07876050
- Acronym / sponsor ID
- VIVAN-44115
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Vivance GroupIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-group, open-label, decentralized clinical trial evaluating the effects of the Kaia Relief - Cycle System (a commercial dietary supplement consisting of Day and Night capsules) on premenstrual symptom severity, menstrual discomfort, and overall well-being in premenopausal women. Forty-five healthy premenopausal women aged 18-45 with regular menstrual cycles and self-reported recurrent premenstrual symptoms will be enrolled.
The study spans approximately 12 weeks across three consecutive menstrual cycles. Cycle 1 serves as a no-product baseline cycle during which participants complete validated questionnaires on Day 5. During Cycles 2 and 3, participants take two Day capsules each morning and two Night capsules each evening, beginning 7 days before their anticipated period and continuing through Day 2 of their cycle. Questionnaires are completed on Day 5 of each product cycle. All study activities are conducted remotely via the Citruslabs digital study platform; there are no in-person visits, blood draws, or laboratory procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kaia Relief - Cycle System (Day and Night) Arm | Experimental | Dietary Supplement: Kaia Relief - Cycle System (Day and Night) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female sex assigned at birth and currently premenopausal.
- Aged 18 to 45 years (inclusive) at the time of informed consent.
- Regular menstrual cycles with a cycle length of 24-35 days for at least the three months prior to enrollment.
- Self-reported recurrent premenstrual symptoms (physical and/or mood) that the participant confirms resolve within a few days of menses onset, occurring in the majority of cycles over the past three months.
- Self-reported premenstrual symptoms of at least moderate severity, defined as symptoms the participant describes as bothersome enough to interfere with normal daily activities, in the majority of cycles over the past three months.
Key exclusion criteria (15 listed)
- Pregnant, breastfeeding, trying to conceive, or planning to become pregnant during the study period.
- Peri-menopausal or post-menopausal status (self-report or known clinical diagnosis).
- Started, stopped, or changed hormonal birth control (including oral contraceptives, hormonal IUD, patch, ring, or injectable hormonal contraceptives) within the three months prior to enrollment, or planning to change hormonal contraception during the study.
- Known allergy or sensitivity to any ingredient in the study product, including allergy to plants of the Asteraceae/Compositae family (e.g., ragweed, chrysanthemum, marigold, yarrow) or to lavender or sweet orange essential oils.
- Diagnosed reproductive condition currently under active pharmacological treatment (e.g., polycystic ovary syndrome [PCOS], endometriosis, uterine fibroids) where treatment may confound premenstrual symptom assessment.
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 |
|---|---|---|
| Kaia Relief - Cycle System (Day and Night)All enrolled participants receive the Kaia Relief - Cycle System (two Day capsules each morning and two Night capsules each evening with food) beginning 7 days before their anticipated period and continuing through Day 2 of their cycle, during Cycles 2 and 3. | Dietary supplement | Kaia Relief - Cycle System (Day and Night) Arm |
Primary outcome
Change in Premenstrual and Menstrual Discomfort Symptoms as Assessed by the Menstrual Symptom Questionnaire (MSQ)
Time frame: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)
Mean change in MSQ total score, calculated according to the Chesney \& Tasto method including applicable reverse-scoring, from Baseline (Day 5 of Cycle 1) to the end of Cycle 3 (Day 5 of Cycle 3)
Change in Menstrual Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)
Mean change in NPRS score from Baseline (Day 5 of Cycle 1) to the end of Cycle 3 (Day 5 of Cycle 3)
1 secondary outcome
Participant-Perceived Effects on Premenstrual Symptoms
Time frame: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaia Relief - Cycle System (Day and Night) in people with Premenstrual Syndrome and Menstrual Discomfort, run by Vivance Group 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 11 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Renner (42424250284, hello@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Premenstrual and Menstrual Discomfort Symptoms as Assessed by the Menstrual Symptom Questionnaire (MSQ) (time frame: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.