[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582531":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":34,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":34,"maxAge":34,"enrollmentInfo":80,"targetDuration":34,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":34,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ospedale Policlinico San Martino","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A1 with 3 capsules","ACTIVE_COMPARATOR","Tablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and two before bedtime for 12 weeks",[13],"Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABA",{"label":15,"type":16,"description":17,"interventionNames":18},"Group A2 with 3 capsules","PLACEBO_COMPARATOR","Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks",[19],"Other: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Group B1 with 2 capsules","Tablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and one before bedtime for 12 weeks",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Group B2 with 2 capsules","Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","GAMMA-AMINOBUTYRIC ACID - GABA","Food supplement based on GABA and Melissa extract",[9,21],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder",[15,25],[40],{"name":41,"affiliation":42,"role":43},"Angelo Cagnacci, MD, PhD","Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"ANGELO CAGNACCI","CONTACT","+39-010-3537728","angelo.cagnacci@unige.it",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Ospedale San Martino","RECRUITING","Genova","Italia","16132","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],11.87211,45.21604,{"lat":63,"lon":62},[66],{"name":46,"role":47,"phone":67,"phoneExt":34,"email":49},"+39 - 010 - 3537728",{"type":43,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Angelo Cagnacci","Full Professor Obstetric and Gynecology - Director Academic Unit of Obstetrics and Gynecology","100582531","evaluation-of-the-beneficial-effects-of-a-product-containing--aminobutyric-acid-gaba-on-climacteric-syndrome-disorders-100582531",false,"NCT06864520","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","GABAPAUSE","Inclusion Criteria:\n\n* Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU\u002FL)\n* Greene Index value ≥ 15\n\nExclusion Criteria:\n\n* Patients who do not consent to the study\n* Patients who have used hormone replacement therapy in the last 3 months\n* Patients who have used phytotherapeutics in the last 3 months\n* Patients who have used acupuncture in the last 3 months\n* Uncompensated hyper or hypothyroidism\n* Acute phase of endocrine pathologies\n* Patients with major psychiatric disorders\n* Addiction to opioids or alcohol\n* Glaucoma\n* Active liver disease\n* Use of antidepressants, benzodiazepines or any neuroactive drug\n* Known allergy to the components of the treatment being studied","FEMALE",{"count":81,"type":82},112,"ESTIMATED","INTERVENTIONAL",[85],"NA","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:\n\n* Does food supplement based on GABA lower the climateric symptoms, such as hot flashes, sleep, disturbances, mood swings?\n* 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.\n\nResearchers 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.\n\nParticipants will:\n\n* Take supplement based on GABA or a placebo every day for 3 months\n* Visit the clinic on day 7, 37 and 97 after enrolment for checkups and tests\n* Keep a diary of number and intensity of hot flashes\n* To fill scales evaluating sleep quality, anxiety, depression and quality of life",[88,89],"Climacteric Symptoms","Hot Flashes","2025-03-04",{"date":92,"type":93},"2025-03-07","ACTUAL",{"date":95,"type":93},"2023-10-25",{"date":97,"type":82},"2025-12",{"name":5,"class":6},1]