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A clinical trial to study the effecs of two drugs, Sharbat -e- Bazoori Moatadil and Nitrofurantoin in children with urinary tract infection.

A Randomized Controlled Clinical Study to Evaluate the Efficacy of Sharbat -e- Bazoori Moatadil Versus Nitrofurantoin in Pediatric Urinary Tract Infection. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097910
Enrollment
50
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Sharbat -e- Bazoori Moatadil: Dose will be administered orally twice a day after meal for 7 days. The dose will be calculated as a fraction of the adult dose of 50 ml- 2 6 yrs: 8.3 ml B
7 9 yrs: 12.5 ml BD
10 15 yrs: 18.8 ml BD
16 18 yrs: 25 ml BD. Control Intervention1: Nitrofurantoin: 5 7 mg/kg/day orally in 4 divided doses for 7 days

Sponsors

State Unani Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both genders aged 3 to 18 years diagnosed with uncomplicated UTI. Signs and symptoms consistent with UTI (e.g., fever, dysuria, frequency, suprapubic pain,) plus a positive urine analysis (pyuria equal or more than 5 WBC per HPF or positive leukocyte esterase per nitrite) or positive urine culture (more than 105 CFU per mL for midstream clean-catch or per local diagnostic cut-offs). First episode or non-complicated recurrent UTI (equal or less than 2 episodes in past 12 months). Patient s guardian or parents willing to sign the informed consent form and follow the study protocol.

Exclusion criteria

Exclusion criteria: Complicated UTI ( e.g., pyelonephritis with systemic toxicity, urosepsis, prostatitis etc.) Structural or functional urinary tract abnormality. Recent antibiotic used ( Use of systemic antibiotics active against urinary pathogens within 48 72 hours prior to screening). Exclude culture sensitive proven Nitrofurantoin resistant cases. Patient is unsure about attending schedule regularly.

Design outcomes

Primary

MeasureTime frame
Urine Analysis and Urine cultureTimepoint: At Baseline 7th Day

Secondary

MeasureTime frame
Change in UTI symptomsTimepoint: At Baseline 3rd Day 7th DAY 14th DAY

Countries

India

Contacts

Public ContactMo Azahar

State Unani Medical College and Hospital

drpedia003@gmail.com9044735150

Outcome results

None listed

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