MenopauseNCT06432816
Efficacy of Nano-Pso Therapy in Menopause
A study testing NANO-PSO in people with Menopause and Vasomotor; Syndrome, run by Distribuidora Biolife SA de CV at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Vasomotor; Syndrome
- What is being tested?
- NANO-PSO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- 28 Feb 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Maternal and Child Institute of the State of Mexico
Toluca, State of Mexico, 50170
LILIANA D ESPARRAGOZA SALAZAR, PH, 527221486139, proyectomenopausiaimiem@gmail.com
ARACELI ESPINOSA GUERRERO, PH
About this study
Official title: Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
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.
Read the detailed description
The menopausal transition in women marks the end of female reproductive capacity and is associated with an estrogenic hormonal imbalance that begins to be noticeable around the fifth decade of life. This process, also known as climacteric, involves the transition from an active to an inactive reproductive stage, and can last for several years before menopause, which is defined as the last menstruation .
During the climacteric, the reduction of estrogen triggers clinical signs and symptoms that affect various systems of the body, such as the central nervous system, the cardio-metabolic system, the musculoskeletal system, and sexual function. Vasomotor symptoms, such as hot flashes, are common manifestations at this stage and affect approximately 75-80% of women in the transition to menopause, with an intensity ranging from moderate to severe in most cases. These symptoms can have a negative impact on quality of life, affecting sleep, functional capacity and work attendance .
Menopausal hormone therapy (MHT) with estrogens and progesterone is the first line of treatment for vasomotor symptoms in menopause. However, some women cannot or prefer not to use MHT due to its adverse effects, which has led to the development of second-line therapies, such as selective serotonin reuptake inhibitors, gabapentinoids, clonidine, and oxybutynin. These non-hormonal therapies may also have minor side effects that may lead to discontinuation of treatment.
In the search for therapeutic alternatives with fewer adverse effects, compounds such as punic acid (omega 5) and its metabolites, such as conjugated linoleic acid, have been investigated. Nanoemulsified pomegranate seed oil (omega 5) has been shown to be a compound with high antioxidant capacity and neuroprotective effects, making it a promising option for the management of symptoms associated with menopause, especially those related to alterations at the level of the menopause. central. Preliminary studies have shown encouraging results in animal models and initial clinical trials, suggesting the need for additional research in specific populations, such as menopausal women.
GENERAL OBJECTIVE
Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early menopause, assessed via the Menopause Rating Scale.
SPECIFIC OBJECTIVES
- Describe the sociodemographic and clinical characteristics of the Study population.
- Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale.
- Compare vasomotor symptoms with the use of NANO-PSO vs. Placebo
- Compare the percentage of treatment response regarding vasomotor symptoms with the use of nano pso vs placebo at 3 and 6 months.
Population study Patients who come first class. outpatient climacteric consultation that presents with early menopause and MRS scale > 15 points without treatment.
With a sample convenience, the aim is to recruit 45 patients per group with a total of 90 patients. Intervention by compounds - Leading to treatment of 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
- 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.
- Conditions
- Menopause, Vasomotor; Syndrome
- Being tested
- NANO-PSO, PLACEBO
- Medical subject headings
- Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NANO-PSODietary supplement
Also called Oil of pomegranate seed with nanotechnology
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
PLACEBOOther
Placebo physically identical to NANO-PSO capsules:
Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
MENOPAUSE RATING SCALE
THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Secondary outcomes (2)
PHQ-9
The PHQ-9 is a nine-item self-report measure that assesses the presence of depressive symptoms based on DSM-IV criteria.
Measured: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
ESTRADIOL
Estradiol is a female sex hormone that regulates many processes in the body in the reproductive age, its evaluation will only be a control.
Measured: EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start28 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Distribuidora Biolife SA de CV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dra Araceli Espinosa Guerrero, Distribuidora Biolife SA de CV
- Investigators
- ARACELI ESPINOSA GUERREO, Principal investigator, Maternal and child institute of the State of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432816
- Sponsor's protocol ID
- IMI-09-23
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24465026Monteleone 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.
PubMed 29393299Avis 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.
PubMed 30401547Kim 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.
PubMed 29462162Petrou 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.
PubMed 34243101Auerbach 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.
PubMed 22240636Mori-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.
PubMed 15099854Valdes-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.
PubMed 33220387Adel-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.
PubMed 35134697Kim 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.
PubMed 25962640Posadzki 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.
PubMed 23497959
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
- ClinicalTrials.gov ID
- NCT06432816
- Acronym / sponsor ID
- IMI-09-23
- Conditions
- Menopause, Vasomotor; Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Distribuidora Biolife SA de CVIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The menopausal transition in women marks the end of female reproductive capacity and is associated with an estrogenic hormonal imbalance that begins to be noticeable around the fifth decade of life. This process, also known as climacteric, involves the transition from an active to an inactive reproductive stage, and can last for several years before menopause, which is defined as the last menstruation .
During the climacteric, the reduction of estrogen triggers clinical signs and symptoms that affect various systems of the body, such as the central nervous system, the cardio-metabolic system, the musculoskeletal system, and sexual function. Vasomotor symptoms, such as hot flashes, are common manifestations at this stage and affect approximately 75-80% of women in the transition to menopause, with an intensity ranging from moderate to severe in most cases. These symptoms can have a negative impact on quality of life, affecting sleep, functional capacity and work attendance .
Menopausal hormone therapy (MHT) with estrogens and progesterone is the first line of treatment for vasomotor symptoms in menopause. However, some women cannot or prefer not to use MHT due to its adverse effects, which has led to the development of second-line therapies, such as selective serotonin reuptake inhibitors, gabapentinoids, clonidine, and oxybutynin. These non-hormonal therapies may also have minor side effects that may lead to discontinuation of treatment.
In the search for therapeutic alternatives with fewer adverse effects, compounds such as punic acid (omega 5) and its metabolites, such as conjugated linoleic acid, have been investigated. Nanoemulsified pomegranate seed oil (omega 5) has been shown to be a compound with high antioxidant capacity and neuroprotective effects, making it a promising option for the management of symptoms associated with menopause, especially those related to alterations at the level of the menopause. central. Preliminary studies have shown encouraging results in animal models and initial clinical trials, suggesting the need for additional research in specific populations, such as menopausal women.
GENERAL OBJECTIVE
Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early menopause, assessed via the Menopause Rating Scale.
SPECIFIC OBJECTIVES
- Describe the sociodemographic and clinical characteristics of the Study population.
- Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale.
- Compare vasomotor symptoms with the use of NANO-PSO vs. Placebo
- Compare the percentage of treatment response regarding vasomotor symptoms with the use of nano pso vs placebo at 3 and 6 months.
Population study Patients who come first class. outpatient climacteric consultation that presents with early menopause and MRS scale > 15 points without treatment.
With a sample convenience, the aim is to recruit 45 patients per group with a total of 90 patients. Intervention by compounds - Leading to treatment of 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NANO-PSO | Active comparator | Dietary Supplement: NANO-PSONANO-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 | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NANO-PSOAlso: Oil of pomegranate seed with nanotechnologyNANO-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 | Dietary supplement | NANO-PSO |
| PLACEBOPlacebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg. | Other | PLACEBO |
Primary outcome
MENOPAUSE RATING SCALE
Time frame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS
FSH HORMONE
Time frame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
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.
PITTSBURG SCALE
Time frame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
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.
STRAW+10
Time frame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause.
2 secondary outcomes
PHQ-9
Time frame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
ESTRADIOL
Time frame: EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 24465026El 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.
- Background: PubMed 29393299Monteleone 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.
- Background: PubMed 30401547Avis 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.
- Background: PubMed 29462162Kim 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.
- Background: PubMed 34243101Petrou 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.
- Background: PubMed 22240636Auerbach 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.
- Background: PubMed 15099854Mori-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.
- Background: PubMed 33220387Valdes-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.
- Background: PubMed 35134697Adel-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.
- Background: PubMed 25962640Kim 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.
- Background: PubMed 23497959Posadzki 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.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARACELI ESPINOSA GUERREO principal investigator
Maternal and child institute of the State of Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NANO-PSO in people with Menopause and Vasomotor; Syndrome, run by Distribuidora Biolife SA de CV at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ARACELI ESPINOSA GUERREO, DRA. (527228228390, araceliespinosa68@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MENOPAUSE RATING SCALE (time frame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06432816, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.