Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Prochlorperazine: Dose 15 mg per day (divided into 3 dose, 5 mg each)
Frequency: Three Times a day Route of administration: Oral
Total duration: 5 Days
Control I
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients in the age group of 18-65 years 2. Patients diagnosed of vestibular migraine based on to ICHD-3 criteria9 3. Patient who has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure
Exclusion criteria
Exclusion criteria: 1. Patients on prochlorperazine or any other anti-vertigo therapy drugs in the past 30 days 2. Patients with history of psychiatric illness in the past 6 months 3. Patients on anti-psychotic or anti-depressant medication in the past 6 months 4. Patients with history of cardiovascular, kidney or liver disorder 5. Patients with suspected or established subcortical brain damage, with or without hypothalamic damage 6. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Number and proportion of MAV patients achieving improvement in Clinical Response, described as worsening (increased by 1 level), no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels), as graded using SVVSLCRE, from baseline (day 0) to day 6, day 15, and day 30. Clinical Response will be assessed using SVVSLRE reading. Clinical response is described as worsening, no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels). [Moderate, Good, Very Good, Excellent]Timepoint: Baseline (day 0) to day 6, day 15, and day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and proportion of patients with improvement in symptoms assessed using scale of vestibular vertigo severity level from baseline to end of treatment period. Symptom severity is graded on the SVVSLCRE (Level I [0–2] absent vestibular vertigo Level V [8-10], very severe vestibular vertigo). The severity of vertigo-associated symptoms (faintness headache, hearing loss, nausea, vomiting, and tinnitus) will be assessed, and symptom severity will be graded based on SVVSLCRETimepoint: Baseline (day 0) to day 6, day 15, and day 30. | — |
Countries
India
Contacts
Public ContactDr M Ilambarathi
ENT Surgeon, IGENT Clinic
Outcome results
None listed