The effect of leech therapy in endometriosis an amphispective clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reduction in pain intensity assessed by visual analog scale
研究概览
简要总结
Title: The effect of leech therapy in endometriosis an amphispective clinical study
Aim and Objectives: To evaluate the effect of leech therapy in endometriosis
To assess the reduction and pelvic pain and dysmenorrhea following leech therapy in endometriotic patients
To observe any changes in menstrual pattern and symptoms related to endometriosis after the treatment
To compare retrospective and prospective clinical outcomes in patients who underwent leech therapy
To document any adverse effects associated with leech therapy in endometriosis
Inclusion criteria: Reproductive age group women between 20 to 40 years
Females diagnosed with endometriosis with or without pelvic pain or secondary dysmenorrhea , heavy menstrual bleeding
Patients willing to participate in the trial by signing informed consent form
Exclusion criteria: Congenital malformation the genital tract
Pelvic malignancy
Bleeding disorders
Severe anaemia hb less than 8 gm
Thrombocytopenia
Lactation first 6 months
Uncontrolled diabetes mellitus ,hypertension ,thyroid function.
Sample Size : 30
Intervention: Patients will receive leech therapy 1 to 4 leeches consecutively for a period of three menstrual cycle at suprapubic region with each session lasting for a period of 45 minutes.
Primary Outcome: Reduction of pain intensity will be assessed by VAS scale in each consecutive cycle
Secondary Outcome : Overall reduction in severity of dysmenorrhea and associated symptoms measured by WaLIDD score before and after intervention
SF 12 QOL questionnaire will be used to assess the intensity of pain and quality of life.
changes in USG for the size of endometriotic lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •females diagnosed with endometriosis with or without pelvic pain or secondary dysmenorrhea heavy menstrual bleeding patients willing to participate in the trail by signing informed consent.
排除标准
- •congenital malformation of the genital tract pelvic malignancy bleeding disorders severe anaemia hb less than 8 gm thrombocytopenia lactation first 6 months uncontrolled diabetes uncontrolled hypertension uncontrolled thyroid function.
结局指标
主要结局
reduction in pain intensity assessed by visual analog scale
时间窗: baseline | 4 weeks | 8 weeks | 12 weeks
次要结局
- overall reduction in severity of dysmenorrhea and associated symtoms assessed by WaLIDD(score)
研究者
Dr A Suhasini
Government nizamia tibbi college