| CTRI Number |
CTRI/2018/07/014797 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
04/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effectiveness and safety of Betahistine in patients with Vertigo |
|
Scientific Title of Study
|
A prospective, open-label, non-comparative study to assess the efficacy and safety of Betahistine in patients with Acute Peripheral Vertigo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BETAD001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Carlton Pereira |
| Designation |
Principal Investigator |
| Affiliation |
Bosco ENT Nursing Home and Research Centre |
| Address |
#135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9819643240 |
| Fax |
|
| Email |
cdpereir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Carlton Pereira |
| Designation |
Principal Investigator |
| Affiliation |
Bosco ENT Nursing Home and Research Centre |
| Address |
#135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9819643240 |
| Fax |
|
| Email |
cdpereir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Carlton Pereira |
| Designation |
Principal Investigator |
| Affiliation |
Bosco ENT Nursing Home and Research Centre |
| Address |
#135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9819643240 |
| Fax |
|
| Email |
cdpereir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Carlton Pereira, Bosco ENT Nursing Homeand Research Centre, #135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai, Maharashtra-400018 |
|
|
Primary Sponsor
|
| Name |
Dr Carlton Pereira |
| Address |
Bosco ENT Nursing Home and Research Centre, #135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai, Maharashtra-400018 |
| Type of Sponsor |
Other [Private Dental College and Hospital] |
|
|
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 Carlton Pereira |
Bosco ENT Nursing Home & Research Centre |
#135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai, Maharashtra-400018
#135,G Floor, Continental Building, Dr. Annie Besant Rd, Worli, Mumbai, Maharashtra-400018
Mumbai
MAHARASHTRA |
9819643240
cdpereir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhatia Hospital Medical Research Society Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Peripheral Vertigo, (1) ICD-10 Condition: H813||Other peripheral vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Betahistine |
Eligible patients will receive the Betahistine at Baseline visit. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 Parkinson’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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the efficacy of betahistine in treatment naïve acute peripheral vertigo patients |
During Treatment period/Study duration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
During the study duration/treatment period. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective, open-label, non-comparative to
assess the effectiveness and safety of Betahistine in patients with Acute Peripheral
Vertigo. Eligible patients will receive the study drug at the baseline visit. Subjects will be monitored throughout the study duration for adverse events, drug to drug interactions.The subject will be in the study for 21 days and subjects are assessed for effectiveness of the treatment during their visits using certain assessment scales. |