Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders

Launched by OSPEDALE POLICLINICO SAN MARTINO · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a food supplement that contains GABA (Gamma-Aminobutyric Acid) to see if it can help relieve symptoms experienced during menopause, such as hot flashes, sleep issues, and mood swings. Researchers want to find out if this supplement is effective and safe for women dealing with these climacteric symptoms. Participants will take either the GABA supplement or a placebo (which looks like the supplement but has no active ingredients) daily for three months. They will also keep a diary to track the number and severity of their hot flashes and complete questionnaires about their sleep quality, anxiety, depression, and overall quality of life.

To participate, women must be in menopause for at least 12 months or 6 months if certain hormone levels are present and have a specific score indicating the severity of their symptoms. However, those who have used hormone therapies, certain herbal treatments, or have specific health issues like major psychiatric disorders or liver disease are not eligible. Participants will visit the clinic for checkups at three different times during the study to monitor their progress. This trial is currently recruiting participants, and the supplement being studied can be found easily in stores and is considered safe for general use.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
• • Greene Index value ≥ 15
• Exclusion Criteria:
• • Patients who do not consent to the study
• • Patients who have used hormone replacement therapy in the last 3 months
• • Patients who have used phytotherapeutics in the last 3 months
• • Patients who have used acupuncture in the last 3 months
• • Uncompensated hyper or hypothyroidism
• • Acute phase of endocrine pathologies
• • Patients with major psychiatric disorders
• • Addiction to opioids or alcohol
• • Glaucoma
• • Active liver disease
• • Use of antidepressants, benzodiazepines or any neuroactive drug
• • Known allergy to the components of the treatment being studied