The health condition studied in this trial is distal ureteric calculi (stones located in the distal part of the ureter). The study focuses on evaluating the efficacy and safety of Deflazacort in combination with Tamsulosin versus Tamsulosin alone for managing this condition. Ureteral Calculi Deflazacort Tamsulosin Ureteral Obstruction Renal Colic Medical Expulsive Therapy Corticosteroids Alpha-Adrenergic Antagonists Pain Management Clinical Trial
Conditions
Interventions
intervention arm of the study consists of patients receiving:
Tamsulosin 0.4 mg (OD)
Deflazacort 30 mg (OD HS),control arm of the study consists of patients receiving:
Tamsulosin 0.4 mg (OD)
Active Comparator Drug,Active Comparator Drug
intervention arm of the study consists of patients receiving: Tamsulosin 0.4 mg (OD) Deflazacort 30 mg (OD HS),control arm of the study consists of patients receiving: Tamsulosin 0.4 mg (OD)
Sponsors
University College of Medical Sciences (University of Delhi), Delhi-110095
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 Individuals aged 18-80 years. 2 Diagnosed with distal ureteric calculi of size less than equal to 10 mm. 3 Have normal urine study analysis.
Exclusion criteria
Exclusion criteria: 1 Patients with absolute indication for surgery such as pyonephrosis, severe hematuria, or large calculi. 2 Discontinuation of medical treatment by the patient. 3 Patients with mental disorders or illness who cannot understand or comply with the study protocol. 4 Patients with known drug allergy or contraindications to Tamsulosin. 5 Patients with urethral stricture or atrophic urethritis in old age. 6 Hepatic or renal insufficiency with deranged LFT or KFT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Deflazacort + Tamsulosin vs Tamsulosin Follow-up at 2nd, 4th, and 6th weeks Rate of calculi expulsion Calculi clearance | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Deflazacort + Tamsulosin vs Tamsulosin Follow-up at 2nd, 4th, and 6th weeks Monitoring of treatment-emergent adverse effects Assessment of derangement in biochemistry/laboratory reports, Pain Management Follow-up at 2nd, 4th, and 6th weeks Visual analogue scale (VAS) Quality of life (PQLI) Analgesic use as per requirement,Decrease in Urinary Tract Infections and Morbidity Follow-up at 2nd, 4th, and 6th weeks Mean rate of sepsis Charlson comorbidity index | — |
Countries
India
Contacts
Public ContactHimanshu Agrawal
University College of Medical Sciences (University of Delhi) & GTBH
Outcome results
None listed