Clinical study on the Safety and Effectiveness of Meftal-P Suspension for Treating Fever in Children

An observational study to evaluate the efficacy and safety of Mefenamic acid (Meftal-P Suspension) in children with febrile illness - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/01/078895

Enrollment

Registered

2025-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: J100- Influenza due to other identifiedinfluenza virus with pneumonia

Interventions

Intervention1: MEFTAL-P Suspension (100 mg/5 mL of Mefenamic Acid) : Meftal-P will be prescribed for 3 times a day daily dose for 3 days. Recommended dosage based on age group 6 months to 2 years: 2

Eligibility

Inclusion criteria

Inclusion criteria: 1.Males and females aged 6 months to less than 18 years. 2.Subject diagnosed with febrile illness i.e., fever ranging between (100.5°F – 104°F). 3.Subject can consume oral medication. 4.Able to give oral/written assent/parental consent from a parent/guardian.

Exclusion criteria

Exclusion criteria: 1.Subjects who have used acetaminophen within 6 hours or ibuprofen, aspirin, or other NSAIDs within 8 hours prior to screening. 2.Subjects with Hypersensitivity to Mefenamic Acid or NSAIDs. 3.History of renal, hepatic impairment, diabetes mellitus, or thrombocytopenia. 4.Moderate or severe dehydration. 5.Severe underlying illness that contraindicates study participation (e.g., kidney disease, etc.)

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy of Mefenamic Acid (MEFTAL-P Suspension) at the standardized dose of (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects. 2. To assess the safety and tolerability of standardized dosing of mefenamic acid (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects.Timepoint: To measure the percentage reduction in fever from baseline (Day 1) at three daily time points (morning, noon, and night) over the 3-day treatment period. Baseline (Day 1) to Day 3	—

Measure

Time frame

1. To evaluate the efficacy of Mefenamic Acid (MEFTAL-P Suspension) at the standardized dose of (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects. 2. To assess the safety and tolerability of standardized dosing of mefenamic acid (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects.Timepoint: To measure the percentage reduction in fever from baseline (Day 1) at three daily time points (morning, noon, and night) over the 3-day treatment period. Baseline (Day 1) to Day 3

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Secondary

Measure	Time frame
To assess the safety profile, monitor adverse events, and determine the time required to achieve sustained normothermia (normal body temperature) The following are the secondary objectives of the study 1 To monitor AEs,SAEs. 2 To determine the time required to achieve sustained normothermia (normal Body Temperature)Timepoint: Baseline (Day 1) to Day 7 Body temperature will be monitored daily during the 3- day treatment period, with follow-up on Day 3 and Day 7. The time it takes for the subject to maintain normal body temperature without fever for a full 24 hours will be recorded.	—

Measure

Time frame

To assess the safety profile, monitor adverse events, and determine the time required to achieve sustained normothermia (normal body temperature) The following are the secondary objectives of the study 1 To monitor AEs,SAEs. 2 To determine the time required to achieve sustained normothermia (normal Body Temperature)Timepoint: Baseline (Day 1) to Day 7 Body temperature will be monitored daily during the 3- day treatment period, with follow-up on Day 3 and Day 7. The time it takes for the subject to maintain normal body temperature without fever for a full 24 hours will be recorded.

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Countries

India

Contacts

Public ContactDr Vanasnt M Khalatkar

Khalatkar Hospital

vasant.khalatkar@gmail.com09823044438

Outcome results

None listed

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