An open label double arm clinical study to compare the effect of kegel exercise with and without Baladi choorna in women with mild to moderate stress urinary incontinence.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in quantity of urine leakage by 1 hour pad test by weighing the pad
研究概览
简要总结
This study is a open-label double arm clinical study to compare the effect of Kegel exercise with and without 6gm of Baladi curna twice daily for a period of 56 days in Women with Mild to Moderate Stress Urinary Incontinence. The study will be conducted in the OPD and IPD of Striroga and Prasuti tantra Deoartment of Amrita School of Ayurveda, Kollam, India. The primary outcome measures will be reduction in quantity of urine leakage assessed by 1 hour pad test by weighing the pad, and the secondary outcome will be improvement in Quality of Life by ICIQ-LUTS QoL Questionnaire. The assessment for both will be done on Day 1 and Day 57.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parous women of age from 40 to 70 years.
- •Positive on cough stress test with simultaneous expulsion of urine along with cough.
- •Positive pad test with gain of greater than 1 g in the 1-hour pad test.
排除标准
- •Participants with clinical presentation of other type of incontinence like, UUI, MUI Participants diagnosed with stress urinary incontinence associated with pelvic organ prolapse and hysterectomy.
- •Participants diagnosed of Urinary Tract Infection.
- •Participants diagnosed with Diabetes Mellitus.
- •Participants allergic towards milk.
- •Participants with urine leakage of greater than or equal to 50gm on 1 hour pad test.
结局指标
主要结局
Reduction in quantity of urine leakage by 1 hour pad test by weighing the pad
时间窗: Assessment by 1 hour pad test by weighing the pad is done on Day 1 and Day 57
次要结局
- Improvement in Quality of Life by ICIQ-LUTS QoL Questionnaire(Assessment by ICIQ-LUTS QoL Questionnaire is done on Day 1 and Day 57)
研究者
Dr Sandra K S
Amrita School Of Ayurveda