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

Premenstrual Syndrome Clinical Trial

Official title:

Investigation of the Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201702
• Other study ID #: 02.01.2024
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: Sakarya University
• Contact: Ahsen DEMIRHAN KAYACIK
• Phone: +90 05423676190
• Email: ahsendemirhan[@]sakarya.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Dietary Supplement:
• 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).

Locations

Country	Name	City	State
Turkey	Sakarya University	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	premenstrual syndrome scale	It is a scale aiming to measure the severity of premenstrual symptoms developed by Gençdogan in 2006 according to DSM III and DSM IV-R. This scale, which is widely used in Turkey, includes 44 statements that the individual marks by thinking about "being in the period of one week before menstruation". The five-point Likert-type PMSQ consists of 9 subscales (depressed affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, bloating). The lowest score that can be obtained from the scale is 44 and the highest score is 220. Sub-dimension scores are obtained by summing the items in these dimensions and the total score of the PMSQ is calculated by summing the sub-dimension scores. Those with a PMSQ total score of more than 50% are classified as PMS positive. A higher PMSQ score indicates more severe premenstrual symptoms. Cronbach's alpha (a) = .75 for the original scale	baseline and at the 8th week
Secondary	WHO Quality Of Life Bref - WHOQOL-BREF	The WHOQOL-BREF consists of (a) Physical health and well-being (seven items); (b) Psychological health and well-being (six items); (c) Social relationships (three items); and (d) Environment (eight items). Each item has a five-point rating scale from 0-4 (or sometimes 1-5); the higher the item score, the better the person's 'quality of life' in the domain covered by that item.	baseline and at the 8th week