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

Perelel Inc.

Status: Completed

Conditions: Women's Health

Treatments: Dietary Supplement: Perelel Health Hormonal Balance Support

Study type: Interventional

Funder types: Industry

Identifiers

NCT06535698

20403

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Hormonal Balance Support Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Perelel Health Hormonal Balance Support