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To stablish the efficacy and safety of the URO-5 compared to Tamsulosin in urolithiasis and nephrolithiasis patients

A comparative, double arm, 45-days,active- controlled, open label study to stablish the efficacy and safety of the URO-5 compared to Tamsulosin in urolithiasis and nephrolithiasis patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/015052
Enrollment
125
Registered
2018-07-26
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: null- Urolithiasis and Nephrolithiasis

Interventions

Intervention1: URO 5: Alkaloids & Saponins Dose: 500 mg Frequency: BID & TID Route of Administration: Oral Total Duration: 45 Days Control Intervention1: Tamsulocin: Tamsulocin Hydrochloride Dose: 0.4

Sponsors

Council of Scientific and Industrial Research National Botanical Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with urolithiasis or nephrolithiasis diagnosed for at least 25 days before the screening visit Ultrasonography with 5 millimeters (0.2 in) sections Signed written informed consent

Exclusion criteria

Exclusion criteria: Pregnancy or lactation Women of childbearing potential not protected by highly effective contraceptive method of birth control Use of oral or injectable antibiotics Laboratory findings at the screening visit, including: Urinary Tract infection ALT or AST >3 ULN, Positive urine pregnancy test

Design outcomes

Primary

MeasureTime frame
To demonstrate the reduction in size of stone by URO-5 compared to Tamsulosin in patients with Urolithiasis and nephrolithiasis from baseline to day 45. To demonstrate the urine stone size expulsion from baseline to day 45. To demonstrate urine stone size expulsion post lithotripsyTimepoint: Day -7 Day 45—

Secondary

MeasureTime frame
To demonstrate the safety & efficacy of the URO-5 as compared with Tamsulosin in urolithiasis and Nephrolithiasis patients from baseline to day 45Timepoint: Day -7 Day 45—

Countries

India

Contacts

Public ContactArchit Deva

King Georges Medical University

sankhwarsn_sn@yahoo.com9415007703

Outcome results

None listed

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