Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201702
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-01-02
Brief Title:
Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome
Sponsor:
Sakarya University
Organization:
Sakarya University
Study Overview
Official Title:
Investigation of the Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 1314 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 Students 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 womens 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 andor 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
Pomegranate is used in a wide range of applications in complementary medicine In studies conducted in the field of womens 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None