The Effect of Turmeric on New Onset Primary Dysmenorrhea

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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Drug: Naproxen; Dietary supplement: Turmeric

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 31 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1/NSAI(nonsteroidal anti-inflammatory agent) group; Patients with naproxen drug therapy for early onset dysmenorrhea.	Drug: Naproxen; use of naproxen twice a day orally in mens time; Other Names: NSAI(nonsteroidal anti-inflammatory agent)
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; use of naproxen twice a day orally in mens time; Other Names: NSAI(nonsteroidal anti-inflammatory agent); Dietary supplement: Turmeric; Use of turmeric orally (1 gram powder formula) in mens time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Batman Training and Research Hospital
• Investigators: Principal Investigator: Erhan Okuyan, Batman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): April 23, 2020
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: naproxen; turmeric; new onset primary dysmenorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Naproxen
• Other Study ID Numbers: BatmanMCHH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No