The Effect of Turmeric on New Onset Primary Dysmenorrhea

NCT ID: NCT04183556

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2020-04-23

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1/NSAI(nonsteroidal anti-inflammatory agent) group

Patients with naproxen drug therapy for early onset dysmenorrhea.

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

use of naproxen twice a day orally in mens time

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)

Group Type: PLACEBO_COMPARATOR

Naproxen

Intervention Type: DRUG

use of naproxen twice a day orally in mens time

Turmeric

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Naproxen

use of naproxen twice a day orally in mens time

Intervention Type: DRUG

Turmeric

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NSAI(nonsteroidal anti-inflammatory agent)

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Batman Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Erhan Okuyan,M.D

Obstetrician and gynaecologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

erhan okuyan

Role: PRINCIPAL_INVESTIGATOR

Batman Training and Research Hospital

Locations

Batman Maternity and Child's health Hospital

Batman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BatmanMCHH

Identifier Type: -

Identifier Source: org_study_id