An interventional study of GAMMA-AMINOBUTYRIC ACID - GABA and Placebo in Climacteric Symptoms and Hot Flashes, sponsored by Ospedale Policlinico San Martino. Recruiting at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Ospedale Policlinico San Martino · Not applicable, Interventional, and Treatment
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:
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:
This study aims to evaluate the effectiveness of a commercial supplement to alleviate symptoms associated with menopause such as hot flashes, sleep disturbances, and mood swings.
Participants will be required to come to the clinic for a few visits:
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 112 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Ospedale Policlinico San Martino is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABA
Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks
Other: Placebo
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
Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABA
Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks
Other: Placebo
Food supplement based on GABA and Melissa extract
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Change of the Greene Climacteric Scale Score
The Greene Scale is a verified measurement tool which provides a brief measure of menopause symptoms. It is composed of 21 items evaluating the bother of climacteric symptoms with a score for each symptom from none (value of 0) to mild (value of 1) to moderate (value of 2) to intense (value of 3). The total score of the ranges from 0 to 63, higher values corresponding to more intense climacteric symptoms. A value equal or greater than 15 indicates the presence of climacteric symptoms
Time frame: From enrollment to the end of treatment at 12 weeks
Assessment of anxiety with the State-Trait Anxiety Inventory-Y1 (STAI-Y1) questionnaire
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of state (Y1) of anxiety with 20 items. It can be used to diagnose anxiety and to distinguish it from depressive syndromes. All items are rated on a 4-point scale (with 1 = not at all and 4 = very much) and the total score is between 20 and 80 with a threshold value predictive of anxious symptoms set at 40. Higher scores are positively correlated with higher levels of anxiety
Time frame: From enrollment to the end of treatment at 12 weeks
Assessment of sleep quality with the Pittsburgh Sleep Quality Index (PSQI) questionnaire
The Pittsburgh Sleep Quality Index assesses sleep quality and disturbances. The global score ranges between 0 and 21, where higher scores indicate worse sleep quality
Time frame: From enrollment to the end of treatment at 12 weeks
Reduction in the number and intensity of hot flashes, assessed with a daily diary 7 days before follow up
Participants report in their daily diary the number and intensity of hot flashes, rating them on a 3-point scale (1 = mild, 2 = moderate, and 3 = severe).
Time frame: From enrollment to the end of treatment at 12 weeks
Assessment of quality of life with the Menopause-specific Quality of Life (MenQoL) questionnaire
The MENQOL consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. The possible score on any item ranges from one to eight, where higher score indicates higher symptoms
Time frame: From enrollment to the end of treatment at 12 weeks
Comparison of the efficacy of two dosages
Time frame: From enrollment to the end of treatment at 12 weeks
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Studies of the drug tested here: Gamma-Aminobutyric Acid
Ospedale Policlinico San Martino