CTRI/2012/04/002544
Recruiting
Phase 4
A Comparative clinical study to evaluate the Efficacy and Safety Of two Cystone formulations for treatment of Renal Calculi.
ConditionsHealth Condition 1: null- Renal stones
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Renal stones
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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