A Clinical Trial On The Efficacy Of Epihysterinum In The Treatment Of Uterine Fibroid
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Improvement in their symptomatology.
研究概览
简要总结
Uterine fibroids are noncancerous growths of the uterus that oftenappear during childbearing years. Also called leiomyomas or myomas[1]. Symptoms of fibroid uterus- asymptomaticin majority (75%), menstrual abnormality: menorrhagia, metrorrhagiadysmenorrhea, dyspareunia, subfertility, pressure symptoms, recurrent pregnancyloss (miscarriage, preterm labor), lower abdominal or pelvic pain,abdominal enlargement. The increasing prevalence and risk of progression of the diseasehas increased the cases of secondary infertility, this demands therapeutic attention. With thisintention, we plan to test the effectiveness of Epihysterinum in uterine fibroid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Self reported and prediagnosed cases of Uterine Fibroids.
- •Patients with symptomatology of Uterine Fibroids.
- •Cases confirmed by USG or Laproscopy.
- •Uterine fibroid of size less than 12 weeks.
排除标准
- •Patients or its guardian unwilling to take part or not giving consent to join the study.
- •Diagnosed cases of systemic diseases psychiatric illness or other uncontrolled or life threatening illness affecting quality of life or any organ failure.
- •Substance abuse and or dependence.
- •Self reported immunecompromised state.
- •Uterine Fibroid of size more than 12 weeks Persistent uterine bleeding despite medical therapy Excessive pain or pressure symptoms Recurrent pregnancy loss due to fibroid/or Rapidly growing myoma.
结局指标
主要结局
Improvement in their symptomatology.
时间窗: 0-3 MONTHS
Improvement in Aberdeen Menorrhagia Severity Scale(AMSS) score.
时间窗: 0-3 MONTHS
次要结局
- uterine fibroids Symptom and Quality of life UFSQOL(0-6 MONTHS)