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To know the effectiveness and safety of Betahistine in patients with Vertigo

A prospective, open-label, non-comparative study to assess the efficacy and safety of Betahistine in patients with Acute Peripheral Vertigo

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014797
Enrollment
70
Registered
2018-07-10
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- Acute Peripheral Vertigo Health Condition 2: H813- Other peripheral vertigo

Interventions

Intervention1: Betahistine: Eligible patients will receive the Betahistine at Baseline visit. Control Intervention1: Not Applicable: Not Applicable

Sponsors

Dr Carlton Pereira
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female aged >=18 years 2.Patients with confirmed peripheral vertigo based on clinical diagnosis 3.Patients naïve to treatment for peripheral vertigo

Exclusion criteria

Exclusion criteria: 1.Patients with middle or inner ear infection, who required surgery 2.Patients suffering from brain tumor, head trauma, epilepsy, multiple sclerosis and paralysis of eye muscles 3.Patient with established psychiatric disorders, significant neurological disorder like Parkinsonâ??s disease or spinal cord damage. 4.Pregnant and lactating women 5.Patients with peptic ulcer 6.Patients with pheochromocytoma 7.Patients with bronchial asthma 8.Patients receiving any other agents for peripheral vertigo such as diuretics, transtympanic gentamycin, cinnarizine, and H1 antagonists (dimenhydrinate, promethazine, diphenhydramine etc.) 9.Patients who are regular users of excessive amount of drugs and alcohol 10.Patients with known hypersensitivity/allergic reaction to Betahistine 11.Participants in any clinical trial in past 30 days before enrollment

Design outcomes

Primary

MeasureTime frame
To establish the efficacy of betahistine in treatment naïve acute peripheral vertigo patientsTimepoint: During Treatment period/Study duration.—

Secondary

MeasureTime frame
1 To evaluate the effect of betahistine on frequency and severity of peripheral vertigo using VNG test. 2 To evaluate the effect of betahistine on severity of peripheral vertigo using DHI and SVVSLCRE scales. Timepoint: During the study duration/treatment period.—

Countries

India

Contacts

Public ContactDr Carlton Pereira

Bosco ENT Nursing Home and Research Centre

cdpereir@gmail.com9819643240

Outcome results

None listed

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