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To evaluate the efficacy of Phenazopyridine with Nitrofurantoin in patients with Urinary tract infection

A Randomized Double blinded Placebo controlled study to evaluate the efficacy of Phenazopyridine with Nitrofurantoin in patients with Urinary tract infection - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068294
Enrollment
120
Registered
2024-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: phenazopyridine tablets: 100mg three times a day for three days Control Intervention1: placebo: three times a day for three days

Sponsors

ANJU JOSHUA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. patients with clinical symptoms or laboratory-documented urinary tract infection 2. patient willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. patients who have taken antibiotics in the last month 2. patients with congenital urinary tract abnormalities 3. patients with severe liver/renal impairment ( GFR 4. lactating women, pregnant women in third trimester 5. patients taking any medicine with clinically significant CYP induction or inhibition of nitrofurantoin or phenazopyridine 6. patients with a history of allergies to nitrofurantoin, phenazopyridine , paracetamol

Design outcomes

Primary

MeasureTime frame
1. clinical symptom improvement with a combination of nitrofurantoin with phenazopyridine 2. adverse drug reactions assessed using WHO-UMC casualty assessment scaleTimepoint: two years

Secondary

MeasureTime frame
adverse drug reaction assessed by WHO-UMC causality assessment scaleTimepoint: two years

Countries

India

Contacts

Public ContactDR SYED SHARIQ NAEEM

Jawaharlal Nehru medical college hospital, Aligarh Muslim University, Aligarh

syedshariq1@gmail.com9634912166

Outcome results

None listed

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