Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.
Not Applicable
Completed
- Conditions
- Women's Health
- Interventions
- Dietary Supplement: Perelel Health Hormonal Balance Support
- Registration Number
- NCT06535698
- Lead Sponsor
- Perelel Inc.
- Brief Summary
This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
- Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid new hormonal balance treatments during the study
- Consistent use of current hormonal balance treatments for at least 3 months prior to the study
Exclusion Criteria
- Chronic conditions preventing adherence to the protocol Diabetes
- Planned hormonal balance-related procedures during the study
- Started any new medications or supplements that target hormonal balance in the past 3 months
- Anyone with diabetes
- Severe allergies requiring EpiPen
- Pregnant, breastfeeding, or trying to conceive
- Recent surgeries or planned surgeries during the study
- Unwilling to follow the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hormonal Balance Support Supplement Perelel Health Hormonal Balance Support Participants in this arm will receive Perelel Health hormonal balance support capsules. The dosage regimen is as follows: Week 1: 1 capsule daily in the evening Week 2: 2 capsules daily in the evening Weeks 3-12: 4 capsules daily (2 in the morning and 2 in the evening) The supplement contains Myo-inositol (1000 mcg), Metabolic balance blend (200 mcg) including Berberine HCl, Alpha lipoic acid, DIM (33'-Diindolylmethane), and D-chiro-inositol (25 mg). Other ingredients include Vegetable cellulose (capsule), plant cellulose, and L-leucine.
- Primary Outcome Measures
Name Time Method Changes in Symptoms of Hormonal Imbalance Baseline, Week 4, Week 8, Week 12 Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire.
- Secondary Outcome Measures
Name Time Method Changes in Overall Menstrual Health Baseline, Week 4, Week 8, Week 12 Assessment of the impact of Perelel Health hormonal balance support on menstrual health using a self-reported questionnaire.
Trial Locations
- Locations (1)
Citruslabs
🇺🇸Santa Monica, California, United States