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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Group B1 with 2 capsules | Active Comparator | 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 |
|
| Group B2 with 2 capsules | Placebo Comparator | Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAMMA-AMINOBUTYRIC ACID - GABA | Dietary Supplement | Food supplement based on GABA and Melissa extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANGELO CAGNACCI | Contact | +39-010-3537728 | angelo.cagnacci@unige.it |
| Name | Affiliation | Role |
|---|---|---|
| Angelo Cagnacci, MD, PhD | Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Martino | Recruiting | Genova | Italia | 16132 | Italy |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| ID | Term |
|---|---|
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Placebo | Other | Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder |
|
| 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 | 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). | 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 | From enrollment to the end of treatment at 12 weeks |
| Comparison of the efficacy of two dosages | From enrollment to the end of treatment at 12 weeks |
| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |