Study on the Effectiveness of a GABA-Based Supplement to Reduce Menopause Symptoms Like Hot Flashes and Mood Changes

What this Trial Is About

Researchers are studying whether a food supplement based on gamma-aminobutyric acid GABA and Melissa extract can help reduce climacteric symptoms experienced during menopause, such as hot flashes, sleep problems, and mood swings. The trial also aims to evaluate the safety of this supplement compared to a placebo, which contains no active ingredients. This study focuses on women experiencing physiological or iatrogenic menopause with significant symptoms as measured by the Greene Index. Participants will be randomly assigned to one of four groups receiving either the GABA supplement or placebo in two different dosages. The supplements are taken as tablets dailyeither three capsules one at lunch and two before bedtime or two capsules one at lunch and one before bedtimefor 12 weeks. Neither participants nor researchers know who receives the supplement or placebo during the study. During the trial, participants will attend clinic visits on days 7, 37, 97, and a final visit to complete symptom diaries and questionnaires assessing hot flashes, sleep quality, anxiety, depression, and quality of life. Researchers will track changes in climacteric symptoms using the Greene Climacteric Scale and other validated tools. The study will monitor participant satisfaction and collect safety information throughout the 3-month treatment period.

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