Description
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.
Eligibility criteria
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:
* 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.