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

NCT ID: NCT06535698

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2024-06-10

Brief Summary

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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

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Conditions

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Women's Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hormonal Balance Support Supplement

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.

Group Type EXPERIMENTAL

Perelel Health Hormonal Balance Support

Intervention Type 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.

Interventions

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Perelel Health Hormonal Balance Support

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

Perelel Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20403

Identifier Type: -

Identifier Source: org_study_id

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