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临床试验/NCT02616731
NCT02616731Unknown1 期

Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD: Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
100
试验地点
1
主要终点
The amount of reducing heavy menstrual flow will be calculated by the PBAC.

研究概览

简要总结

To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women complaining from an menorrhagia secondary to a current copper IUD use.
  • Age: 20-40years.
  • Menorrhagia , will be defined as a PBAC-Score greater than
  • No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
  • No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
  • No drugs decreasing blood coagulation.
  • Well fitted IUD not misplaced.

排除标准

  • Age <20y and >40y.
  • Irregular menstrual cycle.
  • Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
  • Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
  • Taking drugs decrease blood coagulation.
  • Misplaced IUD.

研究组 & 干预措施

Tranexamic acid

Active Comparator

干预措施: Tranexamic Acid (Drug)

Diosmin

Active Comparator

干预措施: Diosmin (Drug)

结局指标

主要结局

The amount of reducing heavy menstrual flow will be calculated by the PBAC.

时间窗: the first 24hours

measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Alanwar

lecturer

Ain Shams University

研究点 (1)

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