MedPath

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

Phase 4
Conditions
Health Condition 1: null- Acute Peripheral VertigoHealth Condition 2: H813- Other peripheral vertigo
Registration Number
CTRI/2018/07/014797
Lead Sponsor
Dr Carlton Pereira
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To establish the efficacy of betahistine in treatment naïve acute peripheral vertigo patientsTimepoint: During Treatment period/Study duration.
Secondary Outcome Measures
NameTimeMethod
1 To evaluate the effect of betahistine on frequency and severity of peripheral vertigo using VNG test. <br/ ><br>2 To evaluate the effect of betahistine on severity of peripheral vertigo using DHI and SVVSLCRE scales. <br/ ><br>Timepoint: During the study duration/treatment period.
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