Health Condition 1: N209- Urinary calculus, unspecified
Conditions
Interventions
Intervention1: Cystone GNX Tablet: One tablet twice daily for 3 months
Control Intervention1: Cystone tablet: Two tablets twice daily for 3 months
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject with Urolithiasis as diagnosed by clinically and ultrasonographically with calculi measuring 5-10mm. 2. Subjects aged between 18-50 years of either sex. 3. Hematologic and Biochemical parameters within normal limits. 4. Willing to sign inform consent document and follow study procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects with severe obstructive uropathy, 2.Subjects with serious systemic medical disorder, 3.Subjects not to have used any drugs for at least 1 week prior to the study, 4.Subjects with a strong history of food or drug allergy, 5.Subjects not to have been on weight reducing diets within 3 months prior to the start of the study, 6.No other drugs (including aspirin) to be ingested during the course of the study, 7.Pregnant and lactating women 8.Patients unwilling to provide informed consent or abide by the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Provide rapid symptomatic recovery and change in clinical and laboratory parameters as compared to baseline.Timepoint: Visit 0- Screening/Day1 Visit 1- Month 1, Visit 2- Month 2, Visit 3- Month 3(End of Study). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety profile of Cystone GNX Tablet and evaluation and reporting of adverse eventsTimepoint: Visit 0- Screening/Day1 Visit 1- Month 1, Visit 2- Month 2, Visit 3- Month 3(End of Study). | — |
Countries
India
Contacts
Public ContactDr KJ Malagi
Kasturba Medical College
Outcome results
None listed