GAMMA-AMINOBUTYRIC ACID - GABA: Food supplement based on GABA and Melissa extract
Placebo: Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
Study 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
Eligibility
Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
* Greene Index value ≥ 15
Exclusion Criteria:
* Patients who do not consent to the study
* 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
Primary outcome measure(s)
Change of the Greene Climacteric Scale Score — From enrollment to the end of treatment at 12 weeks 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
Trial sites (1)
Facility
City
Region
Status
Ospedale San Martino
Genova
Italia
Recruiting
More Ospedale Policlinico San Martino trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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