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

NCT06201702 | Completed

• 1 other identifier: 02.01.2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pomegranate; Premenstrual Syndrome

Keywords

premenstrual syndrome; pomegranate; premenstrual symptom; PMS

Outcome Measures

Primary Outcomes (1)

• premenstrual syndrome scale

  It is a scale aiming to measure the severity of premenstrual symptoms developed by Gençdoğan 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 (α) = .75 for the original scale

  baseline and at the 8th week

Secondary Outcomes (1)

• WHO Quality Of Life Bref - WHOQOL-BREF

  baseline and at the 8th week

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: pomegranate extract

Control group

NO INTERVENTION

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.

Interventions

pomegranate extract 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).

Experimental group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: premenstrual syndrome is a female-specific syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahsen DEMİRHAN KAYACIK

  Sakarya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Midwifery Depatment

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: January 2, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 3, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)