NCT06201702

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

Completed NA Last updated 4 June 2024

What this trial tests

NA trial testing pomegranate extract in Pomegranate in 60 participants. Completed in 3 June 2024.

Timeline

2 January 2024

Primary endpoint
15 May 2024

3 June 2024

Quick facts

Lead sponsor	Sakarya University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	2 January 2024
Primary completion	15 May 2024
Estimated completion	3 June 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• pomegranate extract

Conditions studied

• Pomegranate — all drugs for Pomegranate →
• Premenstrual Syndrome — all drugs for Premenstrual Syndrome →

Sponsor

Sakarya University

Who can join

Adults 18 to 49, female only, with Pomegranate or Premenstrual Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of pomegranate supplementation on symptom severity and quality of life in women with premenstrual syndrome: A randomised controlled trial.
   Demirhan Kayacik A, Hamlaci Başkaya Y, Ilçioğlu K. · · 2025 · cited 2× · PMID 39284531 · DOI 10.1016/j.jad.2024.09.079