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IRCT20260723070321N1 IRCT 2026-08-01 Arak University of Medical Sciences Effect of Hydrochlorothiazide in Treatment of Urinary Tract Infection The Efficacy and Safety of Hydrochlorothiazide as an Adjunct Therapy for Clearing Urinary Tract Infections in Children 2026-09-06 anticipated 74 Recruiting https://irct.ir/trial/91887 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this Randomized Clinical Trial, Participants will be allocated to the Intervention and Control Groups in a 1:1 Ratio using Permuted Block Randomization with a Block Size of Six after Enrollment into the Study. The Unit of Randomization is the Individual Participant. Stratified Randomization will not be used. The Randomization Sequence will be generated Prior to the Initiation of the Study using Statistical Software. Participants will be assigned to the Study Groups According to the Generated Randomization Sequence by the Supervising Investigator. No Specific Allocation Concealment Method will be implemented in this Study. 2-3 Urinary Tract Infection. Intervention 1: Intervention group: Patients receive Antibiotic Therapy as prescribed by the Attending Pediatrician, along with Hydrochlorothiazide (25 mg tablets; manufactured by Aburaihan Pharmaceutical Co., Tehran, Iran) at a dosage of 0.5 mg/kg—administered as a Single daily dose (Maximum 100 mg/day) for 7 days. Intervention 2: Control group: Patient receive Antibiotic therapy for 7 days, as prescribed by the Attending Pediatrician, without Hydrochlorothiazide. Yes - There is a plan to make this available What will be shared: The results examined in the study—such as blood and urine test findings and items covered in checklists—will be shareable after the study participants have been de-identified. When: Data from the study will be available for up to six months after the publication of the results. To whom: Data derived from the study will be available to researchers affiliated with academic and scientific institutions. Conditions: Researchers affiliated with academic and scientific institutions can utilize the data and results of this study for citation purposes and to conduct further research. Where to obtain: To obtain the data and documentation resulting from this study, please contact the project lead via email at arshiakhalili3@gmail.com How to obtain: The applicant must contact the project executor via email, and the results will be sent within one week. arshiakhalili3@gmail.com Comments:
public Arshia Khalili
No. 13, Habibi nejad Lane., Jamaluddin Asadabadi Ave., Rajaei Ave., Arak
Arak Iran (Islamic Republic of) 3813845913 +98 86 3223 7510 arshiakhalili3@gmail.com Arak University of Medical Sciences scientific Arshia Khalili
No13, Habibi Nejad Lane, Jamaluddin AsadaBadi Ave., Rajaei Ave.,
Arak Iran (Islamic Republic of) 3813845913 +98 86 3223 7510 arshiakhalili3@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All Children Aged 1 to 18 Years With Urinary Tract Infection 1 year 18 years Both Anatomical Abnormalities of the Urinary System Such as Labial Adhesions Renal Failure Neurogenic Bladder Voiding Dysfunction N39.0 Urinary tract infection, site not specified Treatment - Drugs Treatment - Drugs Intervention group: Patients receive Antibiotic Therapy as prescribed by the Attending Pediatrician, along with Hydrochlorothiazide (25 mg tablets; manufactured by Aburaihan Pharmaceutical Co., Tehran, Iran) at a dosage of 0.5 mg/kg—administered as a Single daily dose (Maximum 100 mg/day) for 7 days. Control group: Patient receive Antibiotic therapy for 7 days, as prescribed by the Attending Pediatrician, without Hydrochlorothiazide. Eradication of Urinary Tract Infection. Timepoint: Urine Sample Collection 10 Days After Receiving Treatment. Method of measurement: Microscopic examination and culture of urine sample. Improvement of fever after receiving treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of frequent urination after receiving treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of dribbling after receiving treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of Dysuria after receiving Treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of Urgency after receiving Treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of Incontinency after receiving Treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of Abdominal pain after receiving Treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of Malaise after receiving Treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Improvement of irritability after receiving Treatment. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: A checklist of urinary tract infection symptoms that assesses presence and duration of the following: Fever, Urinary frequency, Urinary dribbling, Dysuria, Urgency, urinary incontinence, abdominal pain, Malaise and irritability. Assessment of the drug safety of Hydrochlorothiazide in the treatment of Pediatric Urinary Tract Infections. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: Measurement of Serum Sodium, Potassium, Blood Urea Nitrogen and Creatinine levels via Blood test. Evaluation of the Effectiveness of Hydrochlorothiazide on Symptom Improvement and Eradication of Pediatric Urinary Tract Infection. Timepoint: At the beginning of the study and 10 days after the start of treatment. Method of measurement: Microscopic Examination and Culture of Urine Sample and Checklist. Arak University of Medical Sciences Approved 2026-07-12 Ethics Committee of Arak University of Medical Sciences Payambar-e Azam University Complex, Basij Square, Sardasht Area Arak Markazi Iran (Islamic Republic of)