ClinicalTrials.gg
RecruitingNCT07876050Updated Oct 15, 2026

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.

An interventional study of Kaia Relief - Cycle System (Day and Night) in Premenstrual Syndrome, Menstrual Discomfort and Premenstrual Symptoms, sponsored by Vivance Group. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Vivance Group · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Premenstrual Syndrome
  • Menstrual Discomfort
  • Premenstrual Symptoms

Browse trials for

03

In context

Premenstrual Syndrome

182 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.

This study's planned enrollment of 45 is below the median of 70 across 157 interventional studies indexed under Premenstrual Syndrome.

Browse Premenstrual Syndrome studies →

Lead sponsor

This is the only study on the registry with Vivance Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Kaia Relief - Cycle System (Day and Night) Arm

    Dietary Supplement: Kaia Relief - Cycle System (Day and Night)

Interventions

  • Dietary supplementKaia 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)

  2. 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)

    Time frame: 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

    Time frame: Baseline (Day 5 of Cycle 1) to Day 5 of Cycle 3 (each cycle is 28 days)

07

Study locations

1 of 1 sites recruiting
  • Citruslabs
    Las Vegas, Nevada 89118, United States
    • Patrick Renner · Contact
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07876050
Lead sponsor
Vivance Group
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Patrick Renner
Contact
hello@citruslabs.com
42424250284

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion