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

Phase 3

Completed

• Conditions: Calculus of kidney. Ayurveda Condition: ASMARI,

• Registration Number: CTRI/2022/07/043684
• Lead Sponsor: Jammi Pharmaceuticals Pvt Ltd

Brief Summary

This study is an open-labelled, single-arm, prospective clinical study to evaluate the safety and efficacy of Tab. Lithobin therapy in patients diagnosed with renal calculi.

It is planned to screen and enrol a total of 30 patients for this study. Subjects who will provide assigned informed consent will be evaluated for the inclusion and exclusion criteria. Male and Female subjects aged between 18 and 75 years diagnosed with renal calculi will be enrolled in to this study.

Subjects will receive Tab. Lithobin - 2 tablets twice times daily for 120 days (4 months).

Primary Objective

1. To evaluate the efficacy of Tab. Lithobin in subjects diagnosed with renal calculi over a period of 4 months

Secondary Objective

1. To evaluate the safety of Tab. Lithobin treatment in subjects diagnosed renal calculi

2. To evaluate the dependence on  analgesics for pain management during the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-07
• Study Completion: 2022-09-12
• Last Update Posted: 2023-09-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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 < 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the size or absence of kidney stones from baseline to Day 120	4 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sri Lakshmi Superspeciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sri Lakshmi Superspeciality Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Sambashiva A C

Principal investigator

9742797117

info@samahitha.com