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

RecruitingNAAges any - anyFemaleOspedale Policlinico San Martino
NCT06864520 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 i

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH โ‰ฅ40 IU/L) * Greene Index value โ‰ฅ 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
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What it tests

  • GAMMA-AMINOBUTYRIC ACID - GABA
  • Placebo
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Where

1 site
Ospedale San Martino
Genova, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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