Efficacy of Nano-Pso Therapy in Menopause

NCT06432816 | Recruiting DMC

• 1 other identifier: IMI-09-23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Vasomotor; Syndrome

Outcome Measures

Primary Outcomes (4)

• MENOPAUSE RATING SCALE

  THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS

  1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.

• 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.

  1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.

• 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.

  1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.

• STRAW+10

  The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause.

  1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.

Secondary Outcomes (2)

• PHQ-9

  1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.

• ESTRADIOL

  EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.

Study Arms (2)

NANO-PSO

ACTIVE COMPARATOR

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

Dietary Supplement: NANO-PSO

PLACEBO

PLACEBO COMPARATOR

\- 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.

Other: PLACEBO

Interventions

NANO-PSO DIETARY_SUPPLEMENT

NANO-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

Also known as: Oil of pomegranate seed with nanotechnology

NANO-PSO

PLACEBO OTHER

Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg.

PLACEBO

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Distribuidora Biolife SA de CV: lead

Study Sites (1)

Maternal and Child Institute of the State of Mexico

Toluca, State of Mexico, 50170, Mexico

RECRUITING

Related Publications (11)

• El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24.

  PMID: 24465026 BACKGROUND

• Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.

  PMID: 29393299 BACKGROUND

• Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25.

  PMID: 30401547 BACKGROUND

• Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018.

  PMID: 29462162 BACKGROUND

• Petrou P, Ginzberg A, Binyamin O, Karussis D. Beneficial effects of a nano formulation of pomegranate seed oil, GranaGard, on the cognitive function of multiple sclerosis patients. Mult Scler Relat Disord. 2021 Sep;54:103103. doi: 10.1016/j.msard.2021.103103. Epub 2021 Jun 27.

  PMID: 34243101 BACKGROUND

• Auerbach L, Rakus J, Bauer C, Gerner C, Ullmann R, Wimmer H, Huber J. Pomegranate seed oil in women with menopausal symptoms: a prospective randomized, placebo-controlled, double-blinded trial. Menopause. 2012 Apr;19(4):426-32. doi: 10.1097/gme.0b013e3182345b2f.

  PMID: 22240636 BACKGROUND

• Mori-Okamoto J, Otawara-Hamamoto Y, Yamato H, Yoshimura H. Pomegranate extract improves a depressive state and bone properties in menopausal syndrome model ovariectomized mice. J Ethnopharmacol. 2004 May;92(1):93-101. doi: 10.1016/j.jep.2004.02.006.

  PMID: 15099854 BACKGROUND

• Valdes-Sustaita B, Estrada-Camarena E, Gonzalez-Trujano ME, Lopez-Rubalcava C. Estrogen receptors-beta and serotonin mediate the antidepressant-like effect of an aqueous extract of pomegranate in ovariectomized rats. Neurochem Int. 2021 Jan;142:104904. doi: 10.1016/j.neuint.2020.104904. Epub 2020 Nov 18.

  PMID: 33220387 BACKGROUND

• Adel-Mehraban MS, Tansaz M, Mohammadi M, Yavari M. Effects of pomegranate supplement on menopausal symptoms and quality of life in menopausal women: A double-blind randomized placebo-controlled trial. Complement Ther Clin Pract. 2022 Feb;46:101544. doi: 10.1016/j.ctcp.2022.101544. Epub 2022 Feb 2.

  PMID: 35134697 BACKGROUND

• Kim JH, Kim YJ, Park Y. Conjugated Linoleic Acid and Postmenopausal Women's Health. J Food Sci. 2015 Jun;80(6):R1137-43. doi: 10.1111/1750-3841.12905. Epub 2015 May 11.

  PMID: 25962640 BACKGROUND

• Posadzki P, Lee MS, Moon TW, Choi TY, Park TY, Ernst E. Prevalence of complementary and alternative medicine (CAM) use by menopausal women: a systematic review of surveys. Maturitas. 2013 May;75(1):34-43. doi: 10.1016/j.maturitas.2013.02.005. Epub 2013 Mar 14.

  PMID: 23497959 BACKGROUND

MeSH Terms

Conditions

Syndrome

Interventions

Nano-PSO; Nanotechnology

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Miniaturization; Technology; Technology, Industry, and Agriculture

Study Officials

• ARACELI ESPINOSA GUERREO

  Maternal and child institute of the State of Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ARACELI ESPINOSA GUERREO, DRA.

CONTACT

527228228390; araceliespinosa68@yahoo.com

Liliana D Esparragosa Salazar, MC

CONTACT

527221486139; proyectomenopausiaimiem@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatments were received, previously labeled and randomly drawn by the sponsor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DRA. Araceli Espinosa Guerrero

Model Details: This is a multicenter, prospective, analytical and longitudinal study. A sample calculation was made with a therapeutic efficiency of 30% in vasomotor syndrome, with a result of 210 participants, divided into 3 institutions.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: February 28, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

ME (1)