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

South Valley University

Status and phase: Completed; Phase 3

Conditions: Lower Ureteric Stones

Treatments: Other: Placebo; Drug: Cetirizine; Drug: Tamsulosin; Combination Product: Cetirizine + Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT06754410

SVU.MED.URO016.4.23,5,638

Details and patient eligibility

About

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

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnant, solitary kidney, sensitivity to drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 4 patient groups, including a placebo group

Tamsulosin

Active Comparator group

Description:

All patients of group A received tamsulosin 0.4 mg once daily

Treatment:

Drug: Tamsulosin

Cetirizine

Active Comparator group

Description:

All patients of group B received Cetirizine once daily

Treatment:

Drug: Cetirizine

Cetirizine + Tamsulosin

Active Comparator group

Description:

All patients of group C received Tamsulosin 0.4 mg and Cetirizine once daily

Treatment:

Combination Product: Cetirizine + Tamsulosin

Placebo

Placebo Comparator group

Description:

All patients of group D received Placebo once daily

Treatment:

Other: Placebo