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Clinical Trials/CTRI/2012/04/002544
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.

The Himalaya Drug Company0 sites60 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

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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