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To compare the effectiveness of oral drugs Acetazolamide and Topiramate in post surgery cases of spontaneous brain fluid leaks

Effectiveness of Oral Acetazolamide vs Topiramate after endoscopic repair of spontaneous CSF leaks â?? A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070355
Enrollment
30
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: R299- Unspecified symptoms and signs involving the nervous and musculoskeletal systems

Interventions

Intervention1: Tablet Topiramate: orally for 6 months, starting at 25mg twice daily dose which will be increased to 100mg twice daily dose over next 3 months with monthly dose modification. Control In

Sponsors

Dr Devendra Shekhawat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients who are diagnosed as spontaneous CSF rhinorrhea and who will undergo Endoscopic repair of the leak. All sexes. Revision Endoscopic repair of defect.

Exclusion criteria

Exclusion criteria: Patients with other causes of CSF rhinorrhea. Patients who develop intraop complications which require specific post op management. Patients who develop post op meningitis. Patients who do not give consent for the study. Patients who fail to turn up for follow up assessment. Any contraindication to Magnetic resonance (MR) imaging.

Design outcomes

Primary

MeasureTime frame
Topiramate is a better drug in comparison to Acetazolamide in reducing CSF pressure in post op patients who underwent endoscopic repair of spontaneous CSF leaks.Timepoint: 1 month 3 months and 6 months

Secondary

MeasureTime frame
either drug being better in terms of complaince, cost effectiveness and side effect profile at maximum tolerable dose.Timepoint: 1 month 3 months and 6 months

Countries

India

Contacts

Public ContactDr Devendra Shekhawat

Post graduate institute of medical education and research

virkdoc@hotmail.com9814222220

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026