Actively Recruiting
Efficacy of Nano-Pso Therapy in Menopause
Led by Distribuidora Biolife SA de CV · Updated on 2024-05-29
90
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Nano-Pso Therapy in Menopause
Who Can Participate
Eligibility Criteria
You may qualify if you...
- In perimenopause with vasomotor syndrome and score greater than 15 points staged with the MRS scale
- Agree to participate and sign the informed consent
- No prior treatment to relieve the symptoms of menopause
You will not qualify if you...
- Receiving pharmacological and/or hormonal therapy prescribed for menopause symptoms
- Having psychiatric conditions such as anxiety or depression
- Hysterectomized or surgically induced early menopause
- Smoking
- Malnutrition or low weight with BMI 18.5 kg/m2
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maternal and Child Institute of the State of Mexico
Toluca, State of Mexico, Mexico, 50170
Actively Recruiting
Research Team
A
ARACELI ESPINOSA GUERREO, DRA.
CONTACT
L
Liliana D Esparragosa Salazar, MC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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