se of Cystone polyherbal extract in treatment of kidney Stone.
- Conditions
- Health Condition 1: null- Renal stones
- Registration Number
- CTRI/2012/04/002544
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
1.Patients of either gender with age 18-75 years (Both inclusive)
2.Patients with Renal calculi, diagnosis confirmed by X-ray KUB
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) willing to use a reliable means of contraception (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation
1.Patients having severe acute renal colic.
2.Any systemic disease requiring other medications or requiring surgery for calculus condition.
3.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.
4.Known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI)
5.Any other known urogenital disorders.
6.Known 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
7.Subjects on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
8.Participated in another clinical drug trial within 3 months before recruitment.
9.Pregnancy or breast feeding
10.Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
11.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
12.Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication
13.Subjects who refuse to sign the informed consent document.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the stone size (in mm) or the expulsion of stoneTimepoint: day 30 day 60 and day 90
- Secondary Outcome Measures
Name Time Method Painless expulsion of calculi fragments: <br/ ><br>Reduction in pain: <br/ ><br>Consumption of Analgesics:Timepoint: day 30, day 60 and day 90