Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06864520
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
Sponsor:
Ospedale Policlinico San Martino
Organization:
Study Overview
Official Title:
Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GABAPAUSE
Brief 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
* 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
Detailed Description:
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:
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: