Actively Recruiting
Evaluation of Beneficial Effects of a GABA-Based Product on Menopausal Syndrome Symptoms
Led by Ospedale Policlinico San Martino · Updated on 2025-03-07
112
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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 daily—either three capsules (one at lunch and two before bedtime) or two capsules (one at lunch and one before bedtime)—for 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.
CONDITIONS
Brief Title
Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with physiological or medically induced menopause (amenorrhea for at least 12 months or 6 months with FSH 60 40 IU/L)
- Greene Index score of 15 or higher indicating menopausal symptoms
You will not qualify if you...
- Declines consent to participate in the study
- Used hormone replacement therapy in the last 3 months
- Used phytotherapeutic products in the last 3 months
- Received acupuncture in the last 3 months
- Has uncontrolled hyperthyroidism or hypothyroidism
- Experiencing acute endocrine diseases
- Has major psychiatric disorders
- Addicted to opioids or alcohol
- Has glaucoma
- Has active liver disease
- Currently using antidepressants, benzodiazepines, or other neuroactive drugs
- Known allergy to any component of the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take the study product or placebo daily for 12 weeks while completing questionnaires and hot flash diaries at scheduled visits.
4 visits (in-person) over 12 weeks
Trial Site Locations
Total: 1 location
1
Ospedale San Martino
Genova, Italia, Italy, 16132
Actively Recruiting
Research Team
A
ANGELO CAGNACCI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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