Efficacy of Nano-Pso Therapy in Menopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorDistribuidora Biolife SA de CV
About this trial
Vasomotor syndrome is prevalent in 85% of postmenopausal women, hormone therapy in menopause is first-line therapy, but 38% of patients have some contraindication for its use. The medications indicated in this population presents adverse reactions, such as dryness of the mucous membranes, and insomnia in patients, and triggers to abandoned treatment due to poor response to the drug. Aligned with the safety of patients, we wish to test pomegranate seed oil with nanotechnology (NANOPSO), which has been reported to have positive results at a central level, due to its antioxidant effect, which could impact women in climacteric in a positive way. The study involves the participation of 90 patients divided into two groups, where placebo or Nano-PSO will be administered for 60 days, with a total follow-up of 120 days. It is established that patients must not have received previous treatments for menopausal symptoms. Therefore, it is expected that therapy with NANO-PSO compared to placebo will be more effective in controlling vasomotor symptoms in early menopause after 6 months of treatment evaluated by the MRS scale.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
In perimenopause with vasomotor syndrome and score greater than 15 points staged with the MRS scale
They agree to participate and sign the consent informed.
Without prior treatment to relieve the symptoms of menopause.
Disqualifiers
- With pharmacological and/or hormonal therapy prescribed for menopause symptoms.
With psychiatric pathologies such as anxiety and depression.
Hysterectomized patients or patients with induced menopause surgically early.
Smoking
Trial design
Design model
Parallel
Treatments tested in this trial
NANO-PSO
Dietary supplementNANO-PSO or Oil of pomegranate seed with nanotechnology, they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
PLACEBO
Other interventionPlacebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: NANO-PSOActive comparator 1 intervention
Group B: PLACEBOPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
MENOPAUSE RATING SCALE
THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS
Time frame
1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.2
FSH HORMONE
Follicle-stimulating hormone (FSH) is a pituitary hormone that regulates the reproductive cycle, helps control the menstrual cycle and the production of eggs in the ovaries.
Time frame
1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.3
PITTSBURG SCALE
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire commonly used to evaluate sleep quality in adults. Created by the Department of Psychiatry at the University of Pittsburgh in 1988, the PSQI addresses both qualitative and quantitative aspects of sleep experienced during the month prior to its administration.
Time frame
1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.4
STRAW+10
The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause.
Time frame
1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.Secondary outcomes
1
PHQ-9
The PHQ-9 is a nine-item self-report measure that assesses the presence of depressive symptoms based on DSM-IV criteria.
Time frame
1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.2
ESTRADIOL
Estradiol is a female sex hormone that regulates many processes in the body in the reproductive age, its evaluation will only be a control.
Time frame
EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov