Health Condition 1: N73- Other female pelvic inflammatory diseases Health Condition 2: N70-N77- Inflammatory diseases of female pelvic organs Health Condition 3: M272- Inflammatory conditions of jaws
Conditions
Interventions
Intervention1: Metronidazole Extended-release (ER) 600mg tablets: Patients with dental or gynecological infections will be prescribed Metronidazole ER (600 mg) once daily (OD) for 5 days, while patien
Sponsors
J. B. chemicals & pharmaceuticals LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female patients aged more than 18 years. 2. Patients indicated to receive metronidazole tablets for dental, gynecological, or gastrointestinal infections as per physician s discretion. 3. Patients willing to provide written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergy to Metronidazole Tablets or any component of the formulation. 2. History of significant gastrointestinal (e.g., GERD, peptic ulcers, inflammatory bowel disease) or neurological disorders (e.g., peripheral neuropathy, stroke, Parkinson s disease) that may affect drug absorption or taste perception. 3. Patients requiring hospitalization for their primary condition. 4. Patients currently on medications that may interact with Metronidazole or those on concurrent medications that could interfere with the study outcomes. 5. History of substance abuse (including alcohol, tobacco, or illicit drugs) within the past 3 months, as it may impact compliance, taste perception, and study outcomes. 6. Pregnant or breastfeeding women, or women of childbearing potential 7. Participation in another clinical trial within the last 30 days. 8. Not willing to comply with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of metallic taste with Metronidazole ER tablets as compared to Metronidazole IR tablets during the treatmentTimepoint: Baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events reported during the studyTimepoint: Baseline vs Day 3 vs end of study;Serious adverse events reported during the studyTimepoint: Baseline vs Day 3 vs end of study;Patient reported compliance with Metronidazole ER tablets as compared to Metronidazole IR tablets during the treatmentTimepoint: Baseline to Day 3 to end of study;Change in symptoms and improvement in the underlying condition with Metronidazole ER compared to Metronidazole IR during the treatmentTimepoint: Baseline vs Day 3 vs end of study;Incidence of other associated symptoms with Metronidazole ER compared to Metronidazole IR during the treatmentTimepoint: Baseline vs Day 3 vs end of study | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed