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临床试验/NCT04183556
NCT04183556已完成不适用

The Effect of Turmeric on New Onset Primary Dysmenorrhea

Batman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
the effect of turmeric on visual analog scala at new onset primary dysmenorrhea

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1/NSAI(nonsteroidal anti-inflammatory agent) group

Active Comparator

Patients with naproxen drug therapy for early onset dysmenorrhea.

干预措施: Naproxen (Drug)

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)

干预措施: Naproxen (Drug)

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)

干预措施: Turmeric (Dietary Supplement)

结局指标

主要结局

the effect of turmeric on visual analog scala at new onset primary dysmenorrhea

时间窗: 6 months

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.

次要结局

未报告次要终点

研究者

发起方
Batman Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Erhan Okuyan,M.D

Obstetrician and gynaecologist

Batman Training and Research Hospital

研究点 (1)

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