Clinical trial NCT04183556: The Effect of Turmeric on New Onset Primary Dysmenorrhea
Official title: The Effect of Turmeric on New Onset Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: new onset primary dysmenorrhea
turmeric
naproxen
Lead sponsor: Batman Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: the effect of turmeric on visual analog scala at new onset primary dysmenorrhea
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Maternity and Child's health Hospital
Study officials:
affiliation: Batman Training and Research Hospital
name: erhan okuyan
role: PRINCIPAL_INVESTIGATOR
References: