Efficacy of Nano-Pso Therapy in Menopause

Launched by DISTRIBUIDORA BIOLIFE SA DE CV · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Nano-Pso therapy, which uses pomegranate seed oil enhanced with nanotechnology, to help manage menopause symptoms, particularly hot flashes and night sweats, known as vasomotor syndrome. This condition affects about 85% of women going through menopause, and while hormone therapy is commonly used, many women can’t use it due to health reasons. The trial will include 90 women who are in perimenopause and have not received any previous treatments for their menopause symptoms. Participants will be divided into two groups, with one group receiving the Nano-Pso treatment and the other receiving a placebo (a non-active treatment) over a period of 60 days.

To be eligible for the trial, women must have a specific score on a scale that measures menopause symptoms and agree to participate by signing a consent form. The study is looking for women who do not have any current treatments for menopause symptoms or certain health conditions that could complicate participation, such as anxiety or depression. Participants can expect to attend follow-up appointments over the six months to monitor their symptoms. This research aims to determine if Nano-Pso therapy is more effective than a placebo in alleviating menopause symptoms, which could provide a safer option for women who cannot use traditional hormone therapy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • - 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
• • Malnutrition or low weight determined by a BMI ≤ 18.5Kg/m2
• • Elimination criteria.
• • Who do not attend follow-up to provide their treatment the 1, 2, 3 and 4 months for application of the MRS scale
• • That they leave the study voluntarily.
• • Who present any serious adverse effect to the drug.

Trial Officials