The effect of medicinal leech therapy on the improvement of dysmenorrhea an open labelled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- reduction in pain intensity assessed by Visual Analogue Scale in each consecutive cycle
研究概览
简要总结
Dysmenorrhea is the most common gynaecological complaint in adolescent and young women which incapacitates day to day activities , which includes pelvic and non pelvic pathologies.
Title of the study : The Effect of Medicinal Leech Therapy on the improvement of Dysmenorrhea An Open Labelled Study
Aim : To assess the effect of medicinal leech therapy on the improvement of dysmenorrhea.
Inclusion Criteria : Female patients in the age group of 16 to 40 years with primary and secondary dysmenorrhea.
Exclusion Criteria : The following patients will be excluded from the study
1.Age below 16 and above 40 years
2.Hypertension
3.Patients on anticoagulants
4.Congenital malformation of the genital tract
5.Pelvic malignancies
6.Pregnancy and lactation (upto 6 months)
7.Bleeding disorders like severe anaemia and thrombocytopenia
Sample size : 49
Intervention :Patient will receive leech therapy (2 leeches) at the supra pubic region prior to the onset of menstruation based on the individual cycle for three consecutive cycles with each session lasting 30 minutes or until the leeches detaches spontaneously.
Outcomes : Primary outcome :
reduction in pain intensity assessed by VAS Scale
Secondary outcome
overall reduction in severity of dysmenorrhea and associated symptoms assessed by WaLIDD Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •patient with primary and secondary dysmenorrhea.
排除标准
- •Congenital malformation of the genital tract Pelvic malignancy Bleeding disorders like anaemia less than 7 gm per dl Thrombocytopenia Pregnancy Lactation upto 6 months Hypertension Patient on anticoagulants.
结局指标
主要结局
reduction in pain intensity assessed by Visual Analogue Scale in each consecutive cycle
时间窗: Baseline day 0 | 4 weeks | 8 weeks | 12 weeks
次要结局
- overall reduction in severity of dysmenorrhea & associated symptoms measured by WaLIDD Score(Baseline day 0)
研究者
Dr Husna Begum
Government Nizamia Tibbi College