Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
Ospedale Policlinico San Martino
112 participants
Oct 25, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if the food supplement based on GABA works to treat climateric symptoms. It will also learn about the safety of supplement based on GABA. The main question aims to answer: * Does food supplement based on GABA lower the climateric symptoms, such as hot flashes, sleep, disturbances, mood swings? * The supplement that will be administered is commonly available on the market and can be used without particular precautions. No important side effects are reported. Researchers will compare supplement based on GABA to a placebo (a look-alike substance that contains no active ingredients) to see if supplement based on GABA works to treat climateric symptoms. Participants will: * Take supplement based on GABA or a placebo every day for 3 months * Visit the clinic on day 7, 37 and 97 after enrolment for checkups and tests * Keep a diary of number and intensity of hot flashes * To fill scales evaluating sleep quality, anxiety, depression and quality of life
Eligibility
Inclusion Criteria2
- Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
- Greene Index value ≥ 15
Exclusion Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Food supplement based on GABA and Melissa extract
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06864520