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Efficacy of naproxen alone or with cinnarizine compared to placebo as an abortive treatment of vestibular migraine: a randomised placebo controlled, double blind study

Efficacy of naproxen alone or with cinnarizine compared to placebo as an abortive treatment of vestibular migraine: a randomised placebo controlled, double blind study - VESMINACI

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061262
Enrollment
135
Registered
2024-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: G438- Other migraine

Interventions

None listed

Sponsors

DrJayantee Kalita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients with migraine having dizziness will be evaluated for Vestibular Migraine. The moderate to severe VM patients will be included from Neurology outpatient service, SGPGI during the year 2023 to 2024. The diagnosis of VM will be based on an international headache society criteria for VM.

Exclusion criteria

Exclusion criteria: The patient with existing hearing problem, neurological findings, structural abnormality on CT/ MRI, deafness, vestibular transient ischemic attack, hypertension (BP >160/100 mm Hg), coronary artery disease, hepatic or kidney failure, chronic obstructive airway disease, malignancy, systemic diseases, vasculitis, on cancer chemotherapy, immune suppressants, Page 11 migraine prophylactic treatment, pregnancy, lactation, on oral contraceptive drugs, alcohol (taking >14 drinks per week) or any other addiction, children 65 years and those with history of allergy to naproxen or cinnarizine and not willing to give consent

Design outcomes

Primary

MeasureTime frame
Reduction in vertigo symptom by >1 grade improvement in severity scale at 1 hour of medication.Timepoint: On completion of sample size.

Secondary

MeasureTime frame
1) Complete remission of vertigo at 1 hour 2) Time taken to have best response 3) No recurrence of a vertigo within 24 hours or between 24 to 48 hours 4) Reduction in headache severity 5) Reduction in MIDAS 6) Reduction in photo and phonophobia, motion sensitivity, nausea and vomiting 7) Treatment satisfaction on a 0-100 scale using SF 12 8) Adverse eventsTimepoint: On completion of sample size.

Countries

India

Contacts

Public ContactJayantee Kalita

Sanjay Gandhi Post Graduate Institute of Medical Sciences

jayanteek@yahoo.com05222494177

Outcome results

None listed

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