Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Mexico
Maternal and Child Institute of the State of Mexico
RECRUITING
Toluca
Contact Information
Primary
ARACELI ESPINOSA GUERREO, DRA.
araceliespinosa68@yahoo.com
527228228390
Backup
Liliana D Esparragosa Salazar, MC
proyectomenopausiaimiem@gmail.com
527221486139
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2026-07
Participants
Target number of participants: 90
Treatments
Active_comparator: NANO-PSO
NANO-PSO or Pomegranate seed oil with nanotechnology, capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
Placebo_comparator: PLACEBO
\- Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information: Oil edible, oval shape, 640 mg.
Related Therapeutic Areas
Sponsors
Leads: Distribuidora Biolife SA de CV

This content was sourced from clinicaltrials.gov