Health Condition 1: H811- Benign paroxysmal vertigo
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of Vertigo confirmed by Dix Hallpike or Roll test with at least a duration of 3 months Willingness to adhere to the 48 day Vatha ennai regimen.
Exclusion criteria
Exclusion criteria: Central vertigo or other vestibular disorders (e.g vestibular neuritis). Significant cardiovascular, hepatic, or renal pathology. Hypersensitivity to any ingredient of Vathaennai. Pregnant or lactating women. Concurrent use of other investigational drugs or traditional vertigo remedies. Severe psychiatric illness or cognitive impairment affecting protocol compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in vertigo symptom severity from baseline to Day 48 measured by the Dizziness Handicap InventoryTimepoint: Baseline, fifteen, thirty, forty eight days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life & functional impact assessed using the Dizziness Handicap Inventory DHI Vertigo Symptom Scale VSS & EQ 5D 5L Proportion of participants with conversion from a positive Dix Hallpike or Roll test at baseline to a negative test at Day 15 Day 30 & Day 48 Safety & tolerability of Vatha Ennai assessed through systematic monitoring & reporting of adverse events Preliminary treatment effect size estimation for planning future comparative clinical trials Treatment adherence & feasibility assessed through patient compliance follow up retention & documentation of reasons for missed doses or study visitsTimepoint: Baseline, fifteen, thirty, forty eight days | — |
Countries
India
Contacts
National Institute of Siddha