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

NCT ID: NCT06754410

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-03-01

Brief Summary

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

Detailed Description

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Conditions

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Lower Ureteric Stones

Keywords

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stones , ureter, tamsulosin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Tamsulosin

All patients of group A received tamsulosin 0.4 mg once daily

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

group A take tamsulosin once daily

Cetirizine

All patients of group B received Cetirizine once daily

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

give cetirizine once dailly

Cetirizine + Tamsulosin

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

Group Type ACTIVE_COMPARATOR

Cetirizine + Tamsulosin

Intervention Type COMBINATION_PRODUCT

both once daily

Placebo

All patients of group D received Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

once dailly

Interventions

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Tamsulosin

group A take tamsulosin once daily

Intervention Type DRUG

Cetirizine

give cetirizine once dailly

Intervention Type DRUG

Cetirizine + Tamsulosin

both once daily

Intervention Type COMBINATION_PRODUCT

Placebo

once dailly

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant, solitary kidney, sensitivity to drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa AbdelRazek

Assistant Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qena university hospital

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SVU.MED.URO016.4.23,5,638

Identifier Type: -

Identifier Source: org_study_id