Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
NCT ID: NCT06864520
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
112 participants
INTERVENTIONAL
2023-10-25
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of GABA Modulator AZD7325 on Cutaneous Sensation
NCT02530580
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients
NCT02926573
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
NCT02040532
Effect of Gabapentin on Idiopathic Subjective Tinnitus
NCT00555776
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
NCT02703259
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will be required to come to the clinic for a few visits:
* First visit in which the nature of the study will be explained, the intensity of symptoms will be assessed (using the Greene questionnaire), and the inclusion and exclusion criteria for participation in the study will be assessed. If the participant is eligible for the study, they will be asked to fill out a diary for the next 7 days in which to indicate the daily number and intensity of hot flashes;
* Second visit in which the hot flash diary will be collected and the following questionnaires will be submitted: Greene Scale to determine climacteric symptoms; STAI-Y1 to determine state anxiety (20 questions); SDS to determine the presence of depression (20 questions); PSQI to determine the quality of sleep (9 questions); MenQoL, Quality of life (29 questions). At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following month will be provided; neither the participant nor the investigator are aware of the product provided: study product or placebo;
* Third visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill in all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the first 30 days of treatment. At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following two months will be provided;
* Fourth visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill out all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A1 with 3 capsules
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
GAMMA-AMINOBUTYRIC ACID - GABA
Food supplement based on GABA and Melissa extract
Group A2 with 3 capsules
Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks
Placebo
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
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
GAMMA-AMINOBUTYRIC ACID - GABA
Food supplement based on GABA and Melissa extract
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
Placebo
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GAMMA-AMINOBUTYRIC ACID - GABA
Food supplement based on GABA and Melissa extract
Placebo
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Greene Index value ≥ 15
Exclusion Criteria
* 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
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ospedale Policlinico San Martino
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Angelo Cagnacci
Full Professor Obstetric and Gynecology - Director Academic Unit of Obstetrics and Gynecology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Angelo Cagnacci, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale San Martino
Genova, Italia, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12420
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.