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A study for evaluation of utility of indomethacin in tuberculous meningitis patients

An open label randomized study to evaluate effectiveness of indomethacin in Tuberculous Meningitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011722
Enrollment
300
Registered
2018-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Tuberculous Meningitis

Interventions

Intervention1: standard care plus indomethacin: Apart from standard care, they also receive indomethacin for initial 120 days. In initial one week, indomethacin will be given 25 mg thrice a day, there

Sponsors

Dr Ravi Uniyal
Lead Sponsor
Dr HS Malhotra
Collaborator
Dr Neeraj Kumar
Collaborator
Dr Shweta Pandey
Collaborator
Prof RK Garg
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All Newly diagnosed cases of Tuberculos meningitis fulfilling consensus diagnostic criteria of TBM proposed by Marais et al (Lancet infect Dis 2010;10:803-12)

Exclusion criteria

Exclusion criteria: 1. Patients already taking anti- tubercular drugs or steroids. 2. Patients with renal dysfunction (creatinine more than 1.5 mg/dl) 3. Human immunodeficiency virus disease 4. Patients/ attendants refusing consent

Design outcomes

Secondary

MeasureTime frame
Secondary outcome will be assessed as disability by using modified rankin scale (MRS) Timepoint: at 1 month, 2 months, 3 months and 6 months

Primary

MeasureTime frame
The primary outcome measure will be defined as the presence or non-occurrence of a paradoxical reaction in form of either clinical or radiological worseningTimepoint: Upto 6 months of randomization

Countries

India

Contacts

Public ContactDr Ravi Uniyal

King Georgeâ??s Medical University

ravi.sun.uniyal@gmail.com7408122325

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026