NCT01356355已完成2 期
Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort
Dr .S.B.PATANKAR1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort.
详细描述
- To evaluate the tolerability of ayurvedic preparation, Herbmed Plus in management of ureteral stent discomfort
- To know whether the ayurvedic preparation Herbmed Plus ,can reduce the requirement of analgesics or not
- To know whether the ayurvedic preparation ,Herbmed Plus can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following patients would be enrolled in the study:
- •Age 18-75 years (Both inclusive)
- •Absence of urinary tract infection
- •Absence of lower urinary tract symptoms
- •Absence of urethral catheter
- •Patients with unilateral/bilateral ureteral stentSize of the stent ranging from 4/16 to 6/
- •Patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation.
- •7Able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •Patients having evidence of urinary tract infection.
- •Chronic medication with α-blockers or anticholinergics and severe complications during the procedure
- •Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
- •Any other urogenital disorders.
- •Liver dysfunction, defined as total bilirubin >1.5 x the upper limit of Normal (ULN),Aspartate aminotransferase (AST/SGOT) > 2.5 x ULN, or alanine aminotransferase (ALT/SGPT) >2.5 x ULN.
- •Kidney disease, including serum creatinine level >1.5 x ULN.
- •Subjects on herbal supplements (plant extracts preparations or herbal medicines etc.) within previous 3 months.
- •Participated in another clinical drug trial within 3 months before recruitment.
- •Pregnancy or breast feeding.
- •Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation.
- •Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
- •Patients with psychiatric illness or other condition that would limit compliance with study requirements.
研究组 & 干预措施
Herbmed plus
Experimental
One capsule twice a day daily till ureteral stent in situ
干预措施: Herbmed plus (Drug)
Placebo
Placebo Comparator
One capsule twice a day daily till ureteral stent in situ
干预措施: Placebo (Drug)
Tolterodine
Active Comparator
One capsule twice a day daily till ureteral stent in situ
干预措施: Tolterodine (Drug)
结局指标
主要结局
Comparative study for Safety , Efficacy of Herbmed plus and tolterodine in management of ureteral stent discomfort.
时间窗: 3weeks to 3 months
-To compare the efficacy and safety of the Herbmed plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort viz.Dysuria, Urgency Frequency,Haematuria,Loin and suprapubic pain ,consumption of analgesics.
次要结局
- Tolerability of herbmed plus in management of ureteral stent discomfort(3 weeks to 3 months)
研究者
Dr .S.B.PATANKAR
Amai Charitable Trust,ACE Hospital Pune
Amai Charitable Trust
研究点 (1)
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