CTRI/2012/04/002544招募中4 期
A Comparative clinical study to evaluate the Efficacy and Safety Of two Cystone formulations for treatment of Renal Calculi.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients of either gender with age 18-75 years (Both inclusive)
- •2.Patients with Renal calculi, diagnosis confirmed by X-ray KUB
- •3.Size of the calculi ranging from 04 mm - 09 mm
- •4.Able and willing to give written informed consent and comply with the requirements of the study protocol
- •5.Patients of reproductive potential (males and females) willing to use a reliable means of contraception (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation
排除标准
- •1.Patients having severe acute renal colic.
- •2.Any systemic disease requiring other medications or requiring surgery for calculus condition.
- •3.Complicated cases of Renal Calculi requiring surgical intervention, any condition chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.
- •4.Known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI)
- •5.Any other known urogenital disorders.
- •6.Known 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
- •7.Subjects on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
- •8.Participated in another clinical drug trial within 3 months before recruitment.
- •9.Pregnancy or breast feeding
- •10.Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
- •11.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
- •12.Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication
- •13.Subjects who refuse to sign the informed consent document.
研究者
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