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CompletedNCT04183556Updated Apr 24, 2020

The Effect of Turmeric on New Onset Primary Dysmenorrhea

An interventional study of Naproxen and Turmeric in Primary Dysmenorrhea, sponsored by Batman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Batman Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
16 Years to 35 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • new onset primary dysmenorrhea
  • turmeric
  • naproxen
03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Batman Training and Research Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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)
  2. Non-pregnant and breastfeeding patients
  3. Between 16-35 years old
  4. No anatomic pathology or disease
  5. Lack of active infection
  6. No history of drug use
  7. BMI is less than 25
  8. Those who wish to participate in the study signed the consent form
  9. Smoking, non-alcoholic patients
  10. Patients who completed their treatment and came to the control
  11. Regular menstruation

Exclusion criteria

Exclusion Criteria:

  1. Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
  2. Patients who do not want to participate in the study
  3. Pregnant and nursing patients
  4. Be under 16 years or older than 30 years
  5. Systemic disease
  6. Smoking, alcohol consumption
  7. BMI higher than 25
  8. People with organic pelvic pathology (ovarian cyst, fibroids, polyps)
  9. People with a history of drug use
  10. Patients who discontinue treatment and do not come to control
  11. Irregular menstruation
  12. Any history of contraindication to naproxen
  13. Turmeric allergy history
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    1/NSAI(nonsteroidal anti-inflammatory agent) group

    Patients with naproxen drug therapy for early onset dysmenorrhea.

    Drug: Naproxen

  • Placebo comparator
    2/NSAI+ Turmeric (1 gram oral powder formula per day )

    NSAI(nonsteroidal anti-inflammatory agent) + Turmeric for early onset dysmenorrhea (1 gram oral powder formula in mens time)

    Drug: Naproxen · Dietary Supplement: Turmeric

Interventions

  • DrugNaproxen

    use of naproxen twice a day orally in mens time

    Also known as: NSAI(nonsteroidal anti-inflammatory agent)

  • Dietary supplementTurmeric

    Use of turmeric orally (1 gram powder formula) in mens time

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Batman Maternity and Child's health Hospital
    Batman, 72000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04183556
Lead sponsor
Batman Training and Research Hospital
Responsible party
Erhan Okuyan,M.D (Obstetrician and gynaecologist, Batman Training and Research Hospital) — Principal investigator
First posted
Dec 3, 2019
Start date
Nov 15, 2019
Primary completion
Apr 23, 2020
Completion
Apr 23, 2020
Last update
Apr 24, 2020

Study contacts

erhan okuyan
principal investigator · Batman Training and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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