Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome

NCT ID: NCT06201702

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2024-06-03

Brief Summary

Premenstrual syndrome (PMS) is a common disorder among women of reproductive age. About 40% of women report problems with their menstrual cycle. Pomegranate supplementation is one of the practices that may reduce symptoms of premenstrual syndrome (PMS). This study was planned to determine the effect of pomegranate supplementation on the severity of premenstrual syndrome (PMS) symptoms. In the study to be conducted in 2023 with women diagnosed with PMS living in Sakarya province, the individuals to be included in the study will be determined by snowball sampling method and those who meet the inclusion criteria will participate in the study. The researchers will divide the participants into control and intervention groups by using NCSS (statistical software) in a 1:1 ratio using a simple block randomization approach based on CONSORT guidelines. The individuals in the control group will first be administered the PMSÖ (Premenstrual Syndrome Rating Scale) and no intervention will be made. Participants in the intervention group will be informed about 3 mL pomegranate supplementation 13,14 three times a day for 10 days during 2 menstrual cycles (between 7 days before and 3 days after the estimated onset of menstruation). The test will be repeated at the end of the 2nd month post-intervention. Normality of continuous data will be assessed by Kolmogorov-Smirnov test. Data will be expressed as mean ± SD or median and interquartile range (IQR) as appropriate. Variables will be compared between the two intervention and placebo groups using Student's T-test (parametric data) or Mann-Whitney (non-parametric data) or chi-square tests (for qualitative indices). Analyses of changes from pre-intervention to post-intervention within the identified groups will be performed using the Dependent Two Sample t Test (normally distributed parameters) or Wilcoxon signed rank test (non-normally distributed and categorical parameters). All statistical calculations will be performed with SPSS software version 18.

Detailed Description

Premenstrual syndrome (PMS) is a common disorder among women of reproductive age. Approximately 40% of women report problems with their menstrual cycle. Nonpharmacologic and pharmacologic treatment methods are used to alleviate symptoms. For mild symptoms, the first line of treatment is nonpharmacologic, while severe symptoms are treated with pharmacologic methods, mainly selective serotonin reuptake inhibitors (SSRIs). Recent data suggest that punica granatum (pomegranate) affects estrogen receptors, as do selective estrogen receptor modulators.

Pomegranate is used in a wide range of applications in complementary medicine. In studies conducted in the field of women's health, it is stated that pomegranate reduces menopausal symptoms, despression symptoms, leads to improvements in PCOS (polycystic syndrome) cases, and is frequently used in the prevention of breast cancers.

Due to the side effects of SSRIs, such as nausea and vomiting, fatigue, skin changes and impaired libido, many patients seek alternative natural treatments to alleviate symptoms. Recent studies in the literature report that menopausal women with PCOS and/or breast cancer are turning to punica granatum (pomegranate) instead of SSRIs.

Pomegranate (scientific name: Punica granatum L.) is a plant with estrogen-like effects used as a traditional medicine to treat hormonal imbalances. This fruit is rich in antioxidants such as polyphenols, tannins and anthocyanins. It also has anti mitogenic and phytoestrogenic effects. It also contains the elements calcium, magnesium, iron, zinc, and there are studies in the literature reporting that pomegranate causes a decrease in PMS symptoms for each element it contains.

Considering the antioxidant, phytoestrogen effects and elemental structure of pomegranate, it is thought to be effective in reducing premenstrual syndrome symptoms.

The overall aim of this study was to determine the effect of 8-week pomegranate supplementation on the severity of PMS symptoms.

Conditions

Pomegranate; Premenstrual Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group

Participants in the intervention group will first be pre-tested by filling out the data collection tools, and then they will be informed about 3 mL of pomegranate supplementation three times a day for 10 days during 2 menstrual cycles (between 7 days before and 3 days after the estimated onset of menstruation). The test will be repeated at the end of the 2nd month after the intervention

Group Type: EXPERIMENTAL

pomegranate extract

Intervention Type: DIETARY_SUPPLEMENT

Drink 2 mL of pomegranate extract three times a day for 10 days during the 3 menstrual cycles (from 7 days before to 3 days after the estimated onset of menstruation).

Control group

Participants in the control group will be pre-tested and post-tested after 2 menstrual cycles and at the end of menstrual bleeding. This group will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pomegranate extract

Drink 2 mL of pomegranate extract three times a day for 10 days during the 3 menstrual cycles (from 7 days before to 3 days after the estimated onset of menstruation).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Women who experience PMS complaints (those with a PMSS total score of more than 50%) and who volunteer to participate in the research will be included in our study.

Exclusion Criteria

• History of acute or chronic illness or history of medication and supplement use
• PMSS total score <50%
• Irregular menstrual cycle
• History of allergy to herbal medicine
• Experiencing any stressful event during the intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

yasemin hamlacı başkaya

Head of Midwifery Depatment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahsen DEMİRHAN KAYACIK

Role: STUDY_DIRECTOR

Sakarya University

Locations

Sakarya University

Sakarya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

02.01.2024

Identifier Type: -

Identifier Source: org_study_id