A Clinical Study of Cystone Forte Tablet in Kidney stone

A Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Cystone Forte Tablet in Urolithiasis â?? A Pilot Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/011008

Enrollment

Registered

2017-12-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N209- Urinary calculus, unspecified

Interventions

Intervention1: Cystone Forte: two tablets twice daily everyday starting from day 1 to end of 3 months Control Intervention1: Placebo: two tablets twice daily everyday starting from day 1 to end of 3 m

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
To assess the efficacy of Cystone Forte tablet in comparison with placebo in the management of Urolithiasis. Provide rapid symptomatic recovery. Reporting of adverse eventsTimepoint: Visit 0- At entry visit, baseline Visit 1- At the end of month 1 Visit 2- At the end of month 2 Visit 3- (End of the treatment) At the end of month 3	—

Secondary

Measure	Time frame
To assess the safety of Cystone forte tablet in the management of Urolithiasis. Reporting of adverse eventsTimepoint: Visit 0- At entry visit, baseline Visit 1- At the end of month 1 Visit 2- At the end of month 2 Visit 3- (End of the treatment) At the end of month 3	—

Countries

India

Contacts

Public ContactDrTSenthil Kumar

Tamil Nadu Medical Council

drsenku78@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026