CTRI/2009/091/000946已完成2 期
A phase II, 28 week, Randomized, Double- Blind, Placebo-Controlled, Parallel Group Study to evaluate the safety and efficacy of Herbmed Plus an Ayurvedic formulation in patients with Renal Calculi
AMAI CHARITABLE TRUSTS ACE HOSPITAL PUNE0 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
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. Age 18-75 years (Both inclusive)
- •2. Patients with Renal calculi, diagnosis confirmed by plain X-ray KUB &/or ultrasound KUB/CT scan Kidney
- •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) and 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
- •Patients having acute condition of renal calculi.
- •Any systemic disease requiring other medications of surgery for calculus condition. Complicated cases of Renal Calculi requiring surgical condition
- •Chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.
- •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 for stone disease (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 Investigators 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
- •Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication
- •Subjects who refuse to sign the informed consent document .
研究者
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