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

July 30, 2024 updated by: Perelel Inc.

A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Symptoms of Hormonal Imbalance
Time Frame: 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.
Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Overall Menstrual Health
Time Frame: 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.
Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perelel Inc.

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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