Testing Nano-Pso Therapy for Menopausal Symptoms
Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
This study is testing if a new treatment made from pomegranate seed oil can help women going through menopause feel better by reducing hot flashes and other related symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 45 Years to 55 Years |
| Sex | Female |
| Sponsor | Distribuidora Biolife SA de CV Industry-sponsored |
| Locations | 1 site (Toluca, State of Mexico) |
| Trial ID | NCT06432816 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of Nano-Pso therapy, derived from pomegranate seed oil, in alleviating vasomotor symptoms associated with menopause. The study involves 90 participants who will be randomly assigned to receive either Nano-Pso or a placebo for 60 days, with a total follow-up period of 120 days. Participants must be in perimenopause with significant vasomotor symptoms and have not previously received treatment for these symptoms. The goal is to determine if Nano-Pso can provide a safe alternative to traditional hormone therapy, which many women cannot use due to contraindications or adverse effects.
Who should consider this trial
Good fit: Ideal candidates are perimenopausal women experiencing significant vasomotor symptoms without prior treatment.
Not a fit: Patients currently on hormonal therapy or with psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a safe and effective alternative for managing menopausal symptoms in women who cannot use hormone therapy.
How similar studies have performed: While hormone therapy is well-established, this approach using Nano-Pso is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toluca, State of Mexico
- Maternal and Child Institute of the State of Mexico — Toluca, State of Mexico, Mexico (Recruiting)
Study contacts
- Principal investigator: Araceli Espinosa Guerreo — Maternal and child institute of the State of Mexico
- Study coordinator: Araceli Espinosa Guerreo, Dra.
- Email: araceliespinosa68@yahoo.com
- Phone: 527228228390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.