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Clinical Trials/CTRI/2020/05/025246
CTRI/2020/05/025246
Not yet recruiting
Phase 2

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

Ravi Kant0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: N201- Calculus of ureter

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: N201- Calculus of ureter
Sponsor
Ravi Kant
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Ravi Kant

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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