Primary DysmenorrheaNCT04183556
The Effect of Turmeric on New Onset Primary Dysmenorrhea
A study testing Naproxen and Turmeric in people with Primary Dysmenorrhea, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as 150 patients. Patients who met early-onset dysmenorrhea criteria and who met the inclusion criteria; 150 patients were divided into 2 equal groups, and NSAID during the menstrual cycle, nsai + turmeric 1 gr oral powder form treatment was planned to be started in the other group. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Naproxen and Turmeric
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2019to 23 Apr 2020
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Early-onset primary dysmenorrhea (Definition: Pain that begins in less than 6 months, is not accompanied by infection, begins on the first day of menstruation and ends on the last day of menstruation)
- Non-pregnant and breastfeeding patients
- Between 16-35 years old
- No anatomic pathology or disease
- Lack of active infection
- No history of drug use
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- BMI is less than 25
- Those who wish to participate in the study signed the consent form
- Smoking, non-alcoholic patients
- Patients who completed their treatment and came to the control
- Regular menstruation
Who cannot join
- Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
- Patients who do not want to participate in the study
- Pregnant and nursing patients
- Be under 16 years or older than 30 years
- Systemic disease
- Smoking, alcohol consumption
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- BMI higher than 25
- People with organic pelvic pathology (ovarian cyst, fibroids, polyps)
- People with a history of drug use
- Patients who discontinue treatment and do not come to control
- Irregular menstruation
- Any history of contraindication to naproxen
- Turmeric allergy history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman Maternity and Child's health Hospital
Batman, 72000
About this study
The study was planned as 150 patients. Patients who met early-onset dysmenorrhea criteria and who met the inclusion criteria; 150 patients were divided into 2 equal groups, and NSAID during the menstrual cycle, nsai + turmeric 1 gr oral powder form treatment was planned to be started in the other group. The pain frequency and severity before and after treatment were evaluated by visual analog scale and the two groups were compared.
Read the detailed description
There are scientific publications on the use of turmeric, which constitutes the hypothesis of our study, in branches such as cardiology, neurology, infertility and chest diseases due to its anti-inflammatory, anti-aging properties.
The data are planned to be evaluated by the researchers using the SPSS(Statistical Package for the Social Sciences ) 17.0 program on computer. The responses of all groups to the VAS scores are planned to be entered into the system by using the SPSS program before and after treatment. statistics (number, percentage, mean, standard deviation), chi-square and logistic regression analysis are used to compare categorical variables. Chi-square test and Mann Whitney-U test are planned to be used in comparison between groups.When examining the difference between the groups, if the p value is less than 0.05, it is planned as a proof of significant difference.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Naproxen, Turmeric
- Keywords
- new onset primary dysmenorrhea, turmeric, naproxen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called NSAI(nonsteroidal anti-inflammatory agent)
use of naproxen twice a day orally in mens time
TurmericDietary supplement
Use of turmeric orally (1 gram powder formula) in mens time
| Study group | Role | What they receive |
|---|---|---|
| 1/NSAI(nonsteroidal anti-inflammatory agent) group | Active comparator | Patients with naproxen drug therapy for early onset dysmenorrhea. Receives: Drug: Naproxen |
| 2/NSAI+ Turmeric (1 gram oral powder formula per day ) | Placebo comparator | NSAI(nonsteroidal anti-inflammatory agent) + Turmeric for early onset dysmenorrhea (1 gram oral powder formula in mens time) Receives: Drug: Naproxen; Dietary Supplement: Turmeric |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of turmeric on visual analog scala at new onset primary dysmenorrhea
To determine the effect of turmeric use on pain severity in early onset primary .The minimum pain score for dysmenorrhea is defined as 1 maximal pain score of 10 and a significant difference is planned if there is a significant difference between pretreatment scores and post-treatment scores if at least 50 percent reduction in turmeric use is achieved.It is predicted that there is no significant difference in visual analog scale scoring less than 50 percent and treatment is not effective.
Before and after the treatment of turmeric effect on visual analog scores will be compared and a significant difference will be observed if at least 50 percent improvement is detected.dysmenorrhea using visual analogue scoring.
The percentage of reduction in visual analog scores will be calculated in all patients using turmeric.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start15 Nov 2019
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
- Investigators
- erhan okuyan, Principal investigator, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183556
- Sponsor's protocol ID
- BatmanMCHH
- Status last verified
- Apr 2020
- First submitted
- 24 Nov 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Turmeric on New Onset Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04183556
- Acronym / sponsor ID
- BatmanMCHH
- Conditions
- Primary Dysmenorrhea
- Keywords
- new onset primary dysmenorrhea, turmeric, naproxen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 3 Dec 2019 (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.
The study was planned as 150 patients. Patients who met early-onset dysmenorrhea criteria and who met the inclusion criteria; 150 patients were divided into 2 equal groups, and NSAID during the menstrual cycle, nsai + turmeric 1 gr oral powder form treatment was planned to be started in the other group. The pain frequency and severity before and after treatment were evaluated by visual analog scale and the two groups were compared.
Detailed description
There are scientific publications on the use of turmeric, which constitutes the hypothesis of our study, in branches such as cardiology, neurology, infertility and chest diseases due to its anti-inflammatory, anti-aging properties.
The data are planned to be evaluated by the researchers using the SPSS(Statistical Package for the Social Sciences ) 17.0 program on computer. The responses of all groups to the VAS scores are planned to be entered into the system by using the SPSS program before and after treatment. statistics (number, percentage, mean, standard deviation), chi-square and logistic regression analysis are used to compare categorical variables. Chi-square test and Mann Whitney-U test are planned to be used in comparison between groups.When examining the difference between the groups, if the p value is less than 0.05, it is planned as a proof of significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/NSAI(nonsteroidal anti-inflammatory agent) group | Active comparator | Drug: NaproxenPatients with naproxen drug therapy for early onset dysmenorrhea. |
| 2/NSAI+ Turmeric (1 gram oral powder formula per day ) | Placebo comparator | Drug: Naproxen, Dietary Supplement: TurmericNSAI(nonsteroidal anti-inflammatory agent) + Turmeric for early onset dysmenorrhea (1 gram oral powder formula in mens time) |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Early-onset primary dysmenorrhea (Definition: Pain that begins in less than 6 months, is not accompanied by infection, begins on the first day of menstruation and ends on the last day of menstruation)
- Non-pregnant and breastfeeding patients
- Between 16-35 years old
- No anatomic pathology or disease
- Lack of active infection
Key exclusion criteria (13 listed)
- Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
- Patients who do not want to participate in the study
- Pregnant and nursing patients
- Be under 16 years or older than 30 years
- Systemic disease
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 |
|---|---|---|
| NaproxenAlso: NSAI(nonsteroidal anti-inflammatory agent)use of naproxen twice a day orally in mens time | Drug | 1/NSAI(nonsteroidal anti-inflammatory agent) group, 2/NSAI+ Turmeric (1 gram oral powder formula per day ) |
| TurmericUse of turmeric orally (1 gram powder formula) in mens time | Dietary supplement | 2/NSAI+ Turmeric (1 gram oral powder formula per day ) |
Primary outcome
the effect of turmeric on visual analog scala at new onset primary dysmenorrhea
Time frame: 6 months
To determine the effect of turmeric use on pain severity in early onset primary .The minimum pain score for dysmenorrhea is defined as 1 maximal pain score of 10 and a significant difference is planned if there is a significant difference between pretreatment scores and post-treatment scores if at least 50 percent reduction in turmeric use is achieved.It is predicted that there is no significant difference in visual analog scale scoring less than 50 percent and treatment is not effective. Before and after the treatment of turmeric effect on visual analog scores will be compared and a significant difference will be observed if at least 50 percent improvement is detected.dysmenorrhea using visual analogue scoring. The percentage of reduction in visual analog scores will be calculated in all patients using turmeric.
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 24 Apr 2020.
- Individual participant dataSharing planned: No
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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.
erhan okuyan principal investigator
Batman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen and Turmeric in people with Primary Dysmenorrhea, run by Batman Training and Research Hospital 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 11 inclusion and 13 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 24 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
the effect of turmeric on visual analog scala at new onset primary dysmenorrhea (time frame: 6 months). 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 24 Apr 2020.