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Use of Tamsulosin ,Deflazacort and Tadalafil for treatment of patients with lower ureteric calculi.

A parallel group open labelled randomised controlled trial to compare the spontaneous passage of lower ureteric calculi 5-10 mm in size, upon usage of Tamsulosin alone as control compared with Tamsulosin and Deflazacort in one arm compared with Tamsulosin, Deflazacort and Tadalafil in the second arm.TAnTALUS - TAnTALUS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017550
Enrollment
180
Registered
2019-02-08
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: N201- Calculus of ureter

Interventions

Intervention1: First Arm: Tab Tamsulosin 0.4mg orally daily at bedtime for 3 weeks,and Tab Deflazacort 30 mg orally daily at bedtime for 3 weeks Intervention2: Second Arm: Tab Tamsulosin 0.4mg orally

Sponsors

Dr Jaspreet Singh Sandhu
Lead Sponsor
Dr Abuzar Ahmadi
Collaborator
Dr Puneet Aggarwal
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1Radiologically proven lower ureteric calculi 5-10mm in size 2Normal Renal function tests 3Those without history of any prior ureteric surgery

Exclusion criteria

Exclusion criteria: 1 Infections of the urinary tract(Positive Urine Culture,fever or leucocytosis 2 Grade 3-4 hydronephrosis 3 Diabetes 4 Peptic ulcer disease, 5 History of hypersensitivity to Tadalafil or Corticosteroids 6 Pregnancy. 7 Systolic blood pressure less than 110 mm Hg during their first visit.. 8 History of ureteral surgery 9 Deranged renal function test 10 Patients already on Alfa Blockers

Design outcomes

Primary

MeasureTime frame
Spontaneous Expulsion of the lower third ureteric calculusTimepoint: Patients shall be investigated weekly to confirm spontaneous expulsion,for a total of 3 weeks—

Secondary

MeasureTime frame
Drug adverse effect of GastritisTimepoint: leading to discontinuation of drug or managable with H2 blockers;Drug Adverse effect of HeadacheTimepoint: Appearance and whether leading discontinuation of drug;Drug adverse effect of Orthostatic HypotensionTimepoint: Earliest appearance and whether causing discontinuation of drug;Failure to continue medical management, and reasonsTimepoint: Irrespective of time frame;In men,self assessed improvement in (International Index of Erectile Function(IIEF) ScoresTimepoint: At 03 weeks or whenever discontinuing treatment;Self assesed pain measurementTimepoint: Daily and assessed cumulatively at 3 weeks;Total analgesic consumptionTimepoint: weekly and at 3 weeks—

Countries

India

Contacts

Public ContactDr Abuzar Ahmadi

Command Hospital Kolkata

punaggarwal@gmail.com08800885817

Outcome results

None listed

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