Efficacy of Unani formulation in Pelvic Inflammatory Disease-A randomised standard controlled clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in subjective parameters.
研究概览
简要总结
Pelvic Inflammatory disease is a major health problem of reproductive age women in both developed and developing countries.the actual burden of the disease is unknown but the data from the USA suggests that > 10 %of women of reproductive age have a history of PID. Pelvic inflammatory disease is one o the serious infection facing women today. The sequelae of the PID including tubal infertility, ectopic pregnancy and chronic pelvic pain, other sequelae like tubo-ovarian abscess and pelvic adhesions. An early and accurate diagnosis of PID is of paramount importance for the effective management of the acute illness and for the long term sequelae. Natural ,herbal or traditional medicine is now been seen with an eye of great interest and hope. So it has been decided to conduct a clinical trial with an objective to evaluate the efficacy of Unani formulation in PID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married women age group of 20-40 years Mild to moderate PID as per CDC Criteria (CDC diagnostic criteria i.e. pelvic or lower abdominal pain and uterine / adnexal or cervical motion tenderness and more than or equal to 1 of its minor criteria i.e. fever(101 degree F), abnormal cervical or vaginal mucopurulent discharge, abundant number of WBC on wet mount test of vaginal fluid, elevated ESR or CRP, positive test for cervical infection with N.
- •gonorrhoea or C.
- •trachomatis include in this criteria) Medical diagnosis of uncomplicated pelvic inflammatory disease(Sub-acute PID with mild to moderate signs and symtoms).
排除标准
- •Severe PID and its Complications Pregnant and lactating women Systemic illnesses and malignancies A history of uterine or pelvic or abdominal surgery and less than 30days before treatment.
结局指标
主要结局
change in subjective parameters.
时间窗: before and after treatment
次要结局
- change in objective parameters(before and after treatment)