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
Vivance Group
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.
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
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 eno…
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.
Location
- CitruslabsLas Vegas, Nevada