TO STUDY THE EFFICACY OF INDIVIDUALIZED HOMEOPATHIC MEDICINE IN URINARY INCONTINENCE BY USING ICIQ-UI SCALE:A SINGLE BLIND RANDOMIZED PLACEBO CONTROL TRAIL.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Change in urinary incontinence severity measured using ICIQ-UI Score.
研究概览
简要总结
The study is single blind,randomized,placebo controlled trail to assess the efficacy of individualized homeopathic medicine in urinary incontinence using ICIQ-UI Scale. The study will be conducted in 80 participant which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital ,Vadodara ,Gujrat, India.The study will be conducted in the time duration 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Confirmed Diagnosis of one of the following type of urinary incontinence : stress,urge or mixed urinary incontinence
- •All Socioeconomic Status
- •No current treatment for urinary incontinence 4.patient having consent for the study.
排除标准
- •Patient using other medications or therapies for urinary incontinence.
- •Pregnancy,lactating or postpartum cases in women.
- •Patient with cognitive impairment.
- •Patient with bladder/pelvis abnormality like urethral diverticulum,vesicovaginal fistula or pelvic prolapse in female.
- •Patient suffering fromneurological disorders.
结局指标
主要结局
1.Change in urinary incontinence severity measured using ICIQ-UI Score.
时间窗: 8Weeks to 12Weeks after randomization
Primary Outcome Description:
时间窗: 8Weeks to 12Weeks after randomization
Mean change in the ICIQ-UI total score (range 0–21; higher score = greater severity) from baseline to 12 weeks. The questionnaire will be self-administered by participants and scored as per ICIQ guidelines. Comparison will be made between individualized homeopathic medicine and placebo.
时间窗: 8Weeks to 12Weeks after randomization
次要结局
- 1.To study the efficacy of homeopathic individualized remedies and kegal exercise in cases of urinary incontinence by using ICIQ-UI Scale.(2.To assess the impact of Kegel exercise and placebo combination with kegel exerscise and homeopathic individualized remedies in urinary incontinence.)
研究者
DrFarhana Mohammedzuber Mamji
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL