A Clinical Study To Evaluate The Safety And Efficacy Of Lithobin Tablets In Patients With Renal Calculi

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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/043684

Enrollment

Registered

2022-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Reduction in the size or absence of kidney stones from baseline to Day 120Timepoint: 4 months	—

Secondary

Measure	Time frame
Reduction in the size or absence of kidney stones from baseline to Day 30, 60, 90 To evaluate the safety parameters like LFT, RFT, Hematology, Biochemistry and vitals To evaluate the dependence on analgesics for pain management during the studyTimepoint: Day 30, 60, 90 and 120	—

Countries

India

Contacts

Public ContactSrivatsa G S

Samahitha Research Solutions

sri@samahitha.com06364147979

Outcome results