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Role of additional medicine on ureteric stone expulsion

Role of Low dose Deflazacort with Tamsulosin versus Tamsulosin alone for Medical Expulsion Therapy of Ureteric Stone: A comparative study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048094
Enrollment
130
Registered
2022-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: Deflazacort: Deflazacort tablet (12 mg once daily for 10 days) plus Tamsulosin tablet 0.4 mg once daily for 28 days, ORALLY Control Intervention1: Tamsulosin: Tamsulosin tablet 0.4 mg o

Sponsors

Dr Arka Banerjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects attending surgery OPD with diagnosis of ureteric stone 2.Subjects of either sex aged between 18-60 years. 3.Female subjects of reproductive age group willing to practice a medically accepted means of contraception. 4.Subjects willing to provide written informed consent for this study.

Exclusion criteria

Exclusion criteria: 1.Ureteric stone measured > 10 millimeter in size 2.Patients with fever, high-grade hydronephrosis, acute kidney failure, UTI 3.Patients with history of urinary surgery or endoscopic treatment 4.Patients with Pregnancy, breastfeeding, Diabetes, Chronic kidney disease, peptic ulcer, hypotension, liver failure, Benign Prostate Hyperplasia, Hypertension, 5.Concomitant treatment with alpha-blocker drugs, betablockers, calcium channel blockers or nitrates 6.Declared hypersensitivity to Tamsulosin or corticosteroids

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of low dose Deflazacort and Tamsulosin versus Tamsulosin alone in ureteric stone expulsionTimepoint: . Rate of stone expulsion of stone from ureter in 4 week follow up time

Secondary

MeasureTime frame
To assess symptomatic improvement with low dose Deflazacort when added to Tamsulosin To Find out safety and tolerability of study drugs Timepoint: at day 14 after starting treatment and at day 28 after starting treatment

Countries

India

Contacts

Public ContactHindol Mondal

Malda Medical College

hindolmondal@gmail.com9832296446

Outcome results

None listed

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