The Effect of Turmeric on New Onset Primary Dysmenorrhea

NCT04183556 | Completed DMC

• 1 other identifier: BatmanMCHH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

new onset primary dysmenorrhea; turmeric; naproxen

Outcome Measures

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.

  6 months

Study Arms (2)

1/NSAI(nonsteroidal anti-inflammatory agent) group

ACTIVE COMPARATOR

Patients with naproxen drug therapy for early onset dysmenorrhea.

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)

Drug: Naproxen; Dietary Supplement: Turmeric

Interventions

Naproxen DRUG

use of naproxen twice a day orally in mens time

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

1/NSAI(nonsteroidal anti-inflammatory agent) group; 2/NSAI+ Turmeric (1 gram oral powder formula per day )

Turmeric DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Batman Training and Research Hospital: lead

Study Sites (1)

Batman Maternity and Child's health Hospital

Batman, 72000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Naproxen; Curcumin

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Catechols; Phenols; Benzene Derivatives

Study Officials

• erhan okuyan

  Batman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician and gynaecologist

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: December 3, 2019
• Study Start: November 15, 2019
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)