Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.

NCT06535698 | Completed

• 1 other identifier: 20403
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Women's Health

Keywords

Hormonal Balance Support; Menstrual Cycle; Mood Swings

Outcome Measures

Primary Outcomes (1)

• Changes in Symptoms of Hormonal Imbalance

  Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire.

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (1)

• Changes in Overall Menstrual Health

  Baseline, Week 4, Week 8, Week 12

Study Arms (1)

Hormonal Balance Support Supplement

EXPERIMENTAL

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.

Dietary Supplement: Perelel Health Hormonal Balance Support

Interventions

Perelel Health Hormonal Balance Support DIETARY_SUPPLEMENT

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.

Hormonal Balance Support Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perelel Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 2, 2024
• Study Start: February 19, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)