A comparative clinical study to evaluate the efficacy of lashuna taila uttarbasti and narayana taila uttarbasti in the management of stree bandhyattava w.s.r. tubal blockage
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to evaluate the efficacy of lashuna taila and narayana taila uttarbasti in management of tubal blockage
研究概览
简要总结
this is a randomised comparative clinical study phase 2 parallel group trial . Comparing the efficacy of Lashuna taila uttarbasti and Narayana taila uttarbasti in case of stri bandhyattava for 3 months in 30 patients . The patient fulfilling the cclinical criteria for diagnosis of stri bandhyattava will be randomly selected from OPD / IPD of State Ayurvedic College and Hospital Lucknow and referred cases from other hospitals . a careful history , physical examination and necessary investigations will be performed . further patients divided into two groups , Group A- patient will be treated with Lashuna taila uttarbasti in the dose 3-5 ml through transvaginal route after cessation of menses for 3 alternative days for 3 consecutive cycles in Group B - patient will be treated with Narayana taila uttarbasti in the dose of 3- 5 ml through transvaginal route after cessation of menses for 3 alternative days for 3 concsecative cycles . Follow up period after 30 days with trial drug and last follow up after 30 days of completion of trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Married women with Age between 21 to 40 years.
- •2.Patient of primary and secondary infertility 3.Clinically diagnosed Patients of unilateral or bilateral tubal blockage.
排除标准
- •1.Patient with active and chronic pelvic infections.
- •2.Patient of any Genital organ diseases like- Uterine fibroid.
- •Genital Prolapse Endometriosis, Adenomyosis etc.
- •3.Patient with history of hypdrosalpinx.
- •4.Women of age less than 21 and above than
- •5.Other systemic disorders like hypertension, diabetes, tuberculosis.
- •7.Patient having organic pathology of uterus and adnexal like cervical carcinoma, Cervical Intraepithelial Neoplasia (CIN).
- •And any malignant growth.
- •8.HIV, VDRL, HBsAg positive patient.
结局指标
主要结局
to evaluate the efficacy of lashuna taila and narayana taila uttarbasti in management of tubal blockage
时间窗: after 30 days | after 30 days | after 30 days | after 30 days of trial
Improvement in tubal patency
时间窗: after 30 days | after 30 days | after 30 days | after 30 days of trial
次要结局
- Conception / pregnancy rate(Reduction in associated symptoms of bandhayyatava)