PomegranateNCT06201702
Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome
A study testing pomegranate extract in people with Pomegranate and Premenstrual Syndrome, run by Sakarya University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pomegranate, Premenstrual Syndrome
- What is being tested?
- pomegranate extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- pomegranate extract
- Keywords
- premenstrual syndrome, pomegranate, premenstrual symptom, PMS
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomegranate extractDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and at the 8th week
Secondary outcomes (1)
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.
Measured: baseline and at the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start2 Jan 2024
- Primary completion15 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PomegranateStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasemin hamlacı başkaya, Sakarya University
- Investigators
- Ahsen DEMİRHAN KAYACIK, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201702
- Sponsor's protocol ID
- 02.01.2024
- Status last verified
- Jun 2024
- First submitted
- 2 Jan 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06201702
- Acronym / sponsor ID
- 02.01.2024
- Conditions
- Pomegranate, Premenstrual Syndrome
- Keywords
- premenstrual syndrome, pomegranate, premenstrual symptom, PMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: pomegranate extractParticipants 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 |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pomegranate extractDrink 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). | Dietary supplement | Experimental group |
Primary outcome
premenstrual syndrome scale
Time frame: baseline and at the 8th week
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
1 secondary outcome
WHO Quality Of Life Bref - WHOQOL-BREF
Time frame: baseline and at the 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Pomegranate
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Not yet recruitingObservational study
Clinical Observation of Skin Condition in Patients With Acne Vulgaris Using Ubiquinol, Pomegranate Peel Extract, Ceramide, and Salicylic Acid Emulsion
Acne
Not yet recruitingObservational study
Pomegranate Dietary Supplements in AUD and ALD
Alcohol Use Disorder, Alcohol-associated Liver Disease
Recruiting
Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis
Periodontitis
Active, not recruiting
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Pelvic Organ Prolapse, Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsen DEMİRHAN KAYACIK study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pomegranate extract in people with Pomegranate and Premenstrual Syndrome, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
premenstrual syndrome scale (time frame: baseline and at the 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.