Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study

Phase 3

Completed

• Conditions: Lower Ureteric Stones
• Interventions: Drug: Tamsulosin; Drug: Cetirizine; Combination Product: Cetirizine + Tamsulosin; Other: Placebo

• Registration Number: NCT06754410
• Lead Sponsor: South Valley University

Brief Summary

we investigate the Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination with Alpha Blockers in distal ureter stone

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• all adult patients with lower ureter stone less than 10 mm

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Exclusion Criteria

• pregnant, solitary kidney, sensitivity to drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin	Tamsulosin	All patients of group A received tamsulosin 0.4 mg once daily
Cetirizine	Cetirizine	All patients of group B received Cetirizine once daily
Cetirizine + Tamsulosin	Cetirizine + Tamsulosin	All patients of group C received Tamsulosin 0.4 mg and Cetirizine once daily
Placebo	Placebo	All patients of group D received Placebo once daily

Primary Outcome Measures

Name	Time	Method
ureter stone free rate	4 weeks

Trial Locations

Locations (1)

Qena university hospital; 🇪🇬 Qena, Egypt