A Study to Evaluate the Efficacy, Safety and Tolerability of New Formulation of Dolichos biflorus Seeds in Urolithiasis

Ravi Kant0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients with a diagnosis of symptomatic urolithiasis will be selected to participate in the study.
•2.Eligible patients will be males or non-pregnant, non-lactating females; 18-75 years of age (inclusive of both); with diagnosis of symptomatic urolithiasis disease.
•3.The patients of symptomatic urolithiasis with renal stone burden (<=8 mm), as determined by ultrasound/X-ray KUB.
•4.Patients able to make proper use of medication.
•5.Female patients of childbearing potential - they are willing to use a medically valid and effective contraception throughout the study period.
•6.Patients willing to provide written informed consent

•1.Known hypersensitivity or allergies to any component of the IMP (in any dosage form).
•2.Patients with chronic renal failure, extensive comorbidity, sepsis, and prior metabolic abnormalities.
•3.The patients of symptomatic urolithiasis with renal stone burden ( >8 mm), as determined by ultrasound/X-ray KUB.
•4.The patient required surgical intervention as per clinical judgement by investigator.
•5.The patient with other comorbidity(ies) which prohibit participation of patient in this study as per clinical judgement by investigator.
•6.Use of any investigational drug or investigational device within 30 days prior to randomization.
•7.Patient consumes excessive alcohol, abuses drugs, or has a condition that could compromise the patientâ??s ability to comply with study requirements.
•8.Female patient with ongoing pregnancy.
•9.Patients who are mentally incapacitated such that informed consent cannot be obtained.

发起方

Ravi Kant