A Real-World Study to Compare Metallic Taste Side Effect in Patients Taking Metronidazole Extended-Release and Immediate-Release Tablets

A Prospective, observational, real-world, surveillance study to evaluate the incidence of metallic taste with Metronidazole extended release (ER) tablets and immediate release (IR) tablets - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/06/088246

Enrollment

200

Registered

2025-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: A049- Bacterial intestinal infection, unspecified Health Condition 2: K027- Dental root caries Health Condition 3: N72- Inflammatory disease of cervix uteri

Interventions

Intervention1: Metronidazole ER or IRtablet tablets: Metronidazole ER 600 mg tablet OD or Metronidazole IR400 mg tablet BID or Metronidazole 200 mg tablet BID,for 5 days. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and Female patients aged 18 years or older 2. Patients who have been prescribed Metronidazole Extended-Release (ER) 600 mg tablets or Metronidazole Immediate-Release (IR) 400 mg or 200 mg tablets for the treatment of dental, gynecological, or gastrointestinal infections, as part of routine clinical care and at the discretion of the treating physician. 3. Patients who are willing to provide written informed consent and agree to data sharing for study purposes

Exclusion criteria

Exclusion criteria: 1. Patients who are unwilling to share study-related data. 2. Patients who are unwilling or unable to take the prescribed study medication. 3. Patients who are not available for telephonic follow-up or site visit assessments during the study period

Design outcomes

Primary

Measure	Time frame
Incidence of metallic taste with Metronidazole ER tablets and Metronidazole IR tablets during the treatmentTimepoint: Baseline to End of Study (Day 5)	—

Secondary

Measure	Time frame
Patient reported compliance with Metronidazole ER tablets and Metronidazole IR tablets during the treatmentTimepoint: Baseline to End of Study (Day 5);Change in symptoms and improvement in the underlying condition with Metronidazole ER and Metronidazole IR during the treatmentTimepoint: Baseline to End of Study (Day 5);Incidence of other associated symptoms with Metronidazole ER and Metronidazole IR during the treatmentTimepoint: Baseline to End of Study (Day 5)	—

Measure

Time frame

Patient reported compliance with Metronidazole ER tablets and Metronidazole IR tablets during the treatmentTimepoint: Baseline to End of Study (Day 5);Change in symptoms and improvement in the underlying condition with Metronidazole ER and Metronidazole IR during the treatmentTimepoint: Baseline to End of Study (Day 5);Incidence of other associated symptoms with Metronidazole ER and Metronidazole IR during the treatmentTimepoint: Baseline to End of Study (Day 5)

—

Countries

India

Contacts

Public ContactDr Jay Savai

J. B. chemicals & pharmaceuticals LTD

Jay.Savai@jbpharma.com9833100642

Outcome results

None listed

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