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Evaluation of efficacy of add-on oral ibuprofen in children with tuberculous meningitis aged 1 month - 18 years

Evaluation of the efficacy of add-on oral ibuprofen in children with tuberculous meningitis aged 1 month - 18 years: A single blind, randomized controlled trial - IBTM Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051721
Enrollment
80
Registered
2023-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: A170- Tuberculous meningitis

Interventions

Intervention1: Ibuprofen with standard care: oral ibuprofen 10 mg/kg/dose BD for 4 weeks along with standard care of treatment for TB meningitis Control Intervention1: Standard care: standard care of

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Presenting to department of pediatrics, AIIMS Rishikesh with a diagnosis of TB meningitis as per Maraiâ??s criteria and parents willing to comply with the study protocol and follow up

Exclusion criteria

Exclusion criteria: 1. Preexisting major chronic systemic illness including cardiovascular, respiratory, gastrointestinal system or chronic renal disease 2. Preexisting developmental delay or intellectual disability 3. Already started on ATT for >2 weeks before presenting to our center 4. Caregivers not giving informed consent 5. History of allergy to ibuprofen previously 6. Deranged RFT (serum urea, creatinine or blood urea-nitrogen 7. Total platelet count 8. HIV positivity 9. Children in whom ibuprofen canâ??t be administered orally or through nasogastric tube within 72 hours of presenting to our institute due to clinical contraindications

Design outcomes

Primary

MeasureTime frame
Change in FSS scale score at 4 weeks as compared to baseline in both groupsTimepoint: Change in FSS scale score at 4 weeks as compared to baseline in both groups

Secondary

MeasureTime frame
1. Change in FSS score at 12 weeks as compared to baseline 2. Change in PCPC score at 4 and 12 weeks as compared to baseline 3. Change in radiological severity score at 12 weeks as compared to baseline 4. Mortality at 4 and 12 weeks in both arms 5. Duration of hospitalization in both arms 6. Number of patients with paradoxical reaction within 12 weeks 7. Social quotient by VSMS at 12 weeks 8. Childhood Behavioural Checklist internalizing, externalizing and total score at 12 weeksTimepoint: 4 and 12 weeks

Countries

India

Contacts

Public ContactDr Indar Kumar Sharawat

All India Institute of Medical Sciences, Rishikesh

sherawatdrindar@gmail.com

Outcome results

None listed

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