A Prospective, Single-Center, Open-Labelled Study To Evaluate The Safety And Efficacy Of Lithobin Tablets In Patients With Renal Calculi

Jammi Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1 Age 18-75 years (Both inclusive)
•2 Patients with Renal calculi, diagnosis confirmed by plain X-Ray KUB
•3 Size of the calculi ranging from 04 mm < 1.5 2cm
•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

•1 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.
•2 Subjects is presenting with symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI)
•3 Any other known urogenital disorders.
•4 Subjects on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
•5 Pregnant or breast feeding
•6 Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
•7 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
•8 Actively participating in in other clinical trial or has participated in a clinical trial within the last 30 days.
•9 Unwilling/unable to sign the informed consent
•10 Any condition in the opinion of the investigator that may compromise the safety of the patient by participating in this study

发起方

Jammi Pharmaceuticals Pvt Ltd