Clinical trial to study safty and efficacy of herbmed plusin patient with renal calculi

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

1. Age 18-75 years (Both inclusive)

2. Patients with Renal calculi, diagnosis confirmed by plain X-ray KUB &/or ultrasound KUB/CT scan Kidney

3.Size of the calculi ranging from 04 mm -09 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 (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation

Exclusion Criteria

Patients having acute condition of renal calculi.
Any systemic disease requiring other medications of surgery for calculus condition. Complicated cases of Renal Calculi requiring surgical condition
Chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.
Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction
Any other urogenital disorders.
Liver dysfunction, defined as total bilirubin >1.5 x the upper limit of Normal, (ULN) aspartate aminotransferase (AST/SGOT) > 2.5 x ULN, or alanine aminotransferase (ALT/SGPT) >2.5 x ULN
Kidney disease, including serum creatinine level >1.5 x ULN
Subjects on herbal supplements for stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
; Participated in another clinical drug trial within 3 months before recruitment.
Pregnancy or breast feeding
Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
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
Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication

Subjects who refuse to sign the informed consent document .

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Herbmed plus in patients with urinary calculi by assessing the reduction in the stone size & surface area/ or the expulsion of stoneTimepoint: 210 DAYS

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of Herbmed plus in the management of urinary calculi. Reduction in pain& Consumption of AnalgesicsTimepoint: 210 DAYS