| CTRI Number |
CTRI/2012/07/002779 [Registered on: 09/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
14/06/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine the frequency of occurance of migraine associated vertigo and to assess its response to treatment with flunarizine |
|
Scientific Title of Study
|
Frequency of migraine associated vertigo in patients visiting the audiovestibularclinic in a tertiary care hospital and response to specific treatment for migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 140612 |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Lepcha |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Audiovestibular Unit
Department of ENT
Christian Medical College
Vellore
Vellore
TAMIL NADU
632 004
India |
| Phone |
|
| Fax |
|
| Email |
anjalilepcha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Lepcha |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Audiovestibular Unit
Department of ENT
Christian Medical College
Vellore
TAMIL NADU
632 004
India |
| Phone |
|
| Fax |
|
| Email |
anjalilepcha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Lepcha |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Audiovestibular Unit
Department of ENT
Christian Medical College
Vellore
TAMIL NADU
632 004
India |
| Phone |
|
| Fax |
|
| Email |
anjalilepcha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Fluid research grant, Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Lepcha |
| Address |
Audiovestibular Unit
Department of ENT
Christian Medical College, Vellore |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Lepcha |
Audiovestibular unit |
Department of ENT
Christian Medical College
Vellore
Vellore
TAMIL NADU |
04162286075
anjalilepcha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with migrainous vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flunarizine |
Tab Flunarizine 10mg per oral once daily at bed time for 6 months + symptomatic treatment for acute episodes using Tab Paracetamol 1 gm per oral prn for headache and Tab Betahistine 16mg per oral prn for vertigo |
| Comparator Agent |
Paracetamol and Betahistine for acute episodes |
Symptomatic treatment for acute episodes only with Tab Paracetamol 1gm per oral prn for headache and Tab Betahistine 16 mg per oral prn for vertigo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with migrainous vertigo |
|
| ExclusionCriteria |
| Details |
Any patients with typical history of BPPV (and + Hallpikes test)
Any patients with typical Meniere’s disease (AAOC criteria 1995)
Any patient with past history of chronic discharging ears/history of surgery to ear/ history of permanent hearing loss.
Other neurological disorders i.e. stroke, intracranial tumours
Any patient who is receiving a calcium channel blocker for hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the frequency, severity and duration of vertigo and headaches |
On follow-up after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open-labeled, blocked, randomized trial with two treatment arms. Patients suffering from migraine related vertigo visiting the specialised audiovestibular clinic in CMC hospital are evaluated using a specific questionnaire regarding the patients’ symptoms, past treatment, co-morbidities and family history, followed by a complete clinical examination and audiovestibular tests and appropriate radiological investigations. All patients who qualify for the study are entered serially into a register and block randomized into two treatment arms, with one arm receiving specific migraine directed treatment (flunarizine) and another arm receiving general vertigo treatment. All patients are followed up for six months. The follow is done by a questionnaire that addresses symptom relief, increase or decrease in severity of symptoms and the data is analysed for differences in response to treatment between the two groups. |