A Clinical Study of Cystone Forte Tablet in treating Kidney stone

A Randomized, Open label, Comparative Clinical Study to Evaluate the Efficacy and Safety of Cystone Forte Tablet in Urolithiasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010914

Enrollment

Registered

2017-12-19

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 starting from day 1 to end of 6 weeks Control Intervention1: Tamsulosin capsule: 1 tablet once daily starting from day 1 to end of 6 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Subject with Urolithiasis as diagnosed by clinical with calculi measuring 5 to 12 mm. Hematologic and Biochemical parameters within normal limits (Study specific parameters: calcium, uric acid cannot be more than 2 times upper limit of normal value).Willing to sign inform consent document.

Exclusion criteria

Exclusion criteria: Subjects with severe obstructive uropathy,those with serious systemic medical disorder- Hypertension, Severe Diabetes, Metabolic disorders, Endocrinal disorders, cardiac illness,the subjects not to have used any drugs, for at least 1 week prior to the study for concurrent illness with diabetes and Hypertension. Subjects with a strong history of food or drug allergy of any kind,Subjects not to have been on weight reducing diets within 3 months prior to the start of the study.Pregnant and lactating women Patients unwilling to provide informed consent or abide by the requirements of the study.

Design outcomes

Primary

Measure	Time frame
Recovery in clinical symptoms and signs like Colicky pain at the loin, Hematuria, Dysuria, Nausea/vomiting, frequency of micturition, fever. ï?? Improvement in laboratory parameters: Hematological, Biochemical, Urine, Radiological. Timepoint: Visit 0- Screening Visit Visit 1- At entry visit Visit 2- At the end of week 2 Visit 3- At the end of week 4 Visit 4- (End of the treatment) At the end of week 6	—

Measure

Time frame

Recovery in clinical symptoms and signs like Colicky pain at the loin, Hematuria, Dysuria, Nausea/vomiting, frequency of micturition, fever. ï?? Improvement in laboratory parameters: Hematological, Biochemical, Urine, Radiological. Timepoint: Visit 0- Screening Visit Visit 1- At entry visit Visit 2- At the end of week 2 Visit 3- At the end of week 4 Visit 4- (End of the treatment) At the end of week 6

—

Secondary

Measure	Time frame
Safety profile and overall compliance of Cystone forte tablet in Urolithiasis. Incidence of adverse events during the study period.Timepoint: Visit 0- Screening Visit Visit 1- At entry visit Visit 2- At the end of week 2 Visit 3- At the end of week 4 Visit 4- (End of the treatment) At the end of week 6	—

Countries

India

Contacts

Public ContactDr Rajeev R Chaudhari

Maharashtra Medical council

rrcpune@gmail.com

Outcome results

None listed

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