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临床试验/NCT03016039
NCT03016039Unknown不适用

Curcumin Supplementation for Gynecological Diseases Including Pelvic Inflammatory Disease Endometritis, Endometriosis: A Pilot Study

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年1月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
Change in the Levels of C reactive protein

研究概览

简要总结

To use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian abcess, Endometritis, wound infection.

Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

详细描述

Pelvic inflammatory disease (PID), Endometritis, Wound infection are infections of the female reproductive system. Although PID is a well known pathophysiology the diagnosis method I not well established and its true magnitude is unknown. Many women report that they have been treated for PID when they did not suffer from it and vice versa. Hence the main way to diagnose remains clinical and currently there is no well-established biochemical marker. In endometritis and wound infection the cause may be known but the pathogens involved in the disease formation vary as for this broad spectrum antibiotic is needed.

Aims: To use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected PID, Tubo ovarian abcess, Endometritis, wound infection.

Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

Rational: Curcumin treatment has been shown to safe and efficient in inflammatory states such as in mild-moderate Ulcerative colitis (UC), obesity, and type II diabetes mellitus when used as an add-on to conventional treatment.

In the gynecology and especially in the PID/Tubo ovarian abcess diseases the use of Curcumin as a supplement has never been studied.

研究设计

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

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age above 18
  • The patient was admitted with a diagnosis of Pelvic inflammatory disease / Tubo ovarian abcess, surgical wound infection, Endometritis
  • No Antibiotic treatment was given prior to her recruitment for the study
  • The women is not in menopause

排除标准

  • Age below 18 and above 52
  • Antibiotic treatment was given prior to her recruitment for the study
  • The women is in menopause
  • Pregnant women. Known other inflammatory disease.

结局指标

主要结局

Change in the Levels of C reactive protein

时间窗: at recruitment and after two week and after one month

Change in the Levels of White blood cells

时间窗: at recruitment and after two week and after one month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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