Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorOspedale Policlinico San Martino

About this trial

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 criteria

Qualifiers

Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)

Greene Index value ≥ 15

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GAMMA-AMINOBUTYRIC ACID - GABA
  • Placebo

Treatment groups

112 Participants
are divided into 4 treatment groups