| CTRI Number |
CTRI/2024/06/068528 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
CAROVERINE Versus AMITRIPTYLINE in treatment of tinnitus |
|
Scientific Title of Study
|
EFFICACY AND SAFETY OF CAROVERINE VERSUS AMITRIPTYLINE IN TREATMENT OF TINNITUS. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana mishra |
| Designation |
Post graduate trainee |
| Affiliation |
|
| Address |
Department of ENT
KALINGA INSTITUTE OF MEDICAL SCINNCES
PATIA
BHUBHANESWAR
Khordha
ORISSA
751024
India |
| Phone |
8018931758 |
| Fax |
|
| Email |
2287036@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kabikanta samantaray |
| Designation |
Proffesor |
| Affiliation |
|
| Address |
DEPT OF ENT
KALINGA INSTITUTE OF MEDICAL SCINNCES
PATIA
BHUBHANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9437080638 |
| Fax |
|
| Email |
kabikanta.samantaray@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Archana mishra |
| Designation |
Post graduatee trainee |
| Affiliation |
|
| Address |
DEPT OF ENT
KALINGA INSTITUTE OF MEDICAL SCINNCES
PATIA
BHUBHANESWAR
Khordha
ORISSA
751024
India |
| Phone |
8018931758 |
| Fax |
|
| Email |
2287036@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Department of ENT
KALINGA INSTITUTE OF MEDICAL SCIENECES
PATIA
BHUBHANESWAR
ODISHA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| ARCHANA MISHRA |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
KIMS
PATIA
BHUBHANESWAR
Khordha
ORISSA |
8018931758
2287036@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H931||Tinnitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMITRIPTYLINE |
10MG ONE TAB ONCE DAILY FOR 1 MONTH |
| Comparator Agent |
CAROVERINE |
40mg TWICE daily for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The patients complaining of tinnitus affecting quality of life i.e. THI scoring more than 38.
Idiopathic tinnitus
|
|
| ExclusionCriteria |
| Details |
Vascular lesions of head and inner ear, ICSOL.
Secondary causes of tinnitus.
Eg.external ear and middle ear pathologies, patient on ototoxic drugs.
Patients not willing to give written consent after receiving due instructions.
Contra-indication for caroverine therapy (e.g. severe hypertension)
Pregnancy or plan for having children
Status post psychiatric therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The change in the severity of tinnitus after treatment in patients with tinnitus according to THI scoring at 2 months.
|
8 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
THI scoring at 1 month
The safety of caroverine versus amitriptyline according to CTCAE (Common Terminology Criteria for Adverse Events)
|
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Tinnitus may be defined as conscious awareness of a sound in the absence of an external auditory stimulus. •Tinnitus may be categorised as subjective, objective, primary or secondary. The assessment of tinnitus begins by determining which of these types the patient present with. •Being described its prevalence has been estimated to be as high as 32% in the adult population, with approximately 13%-17% reporting bothersome tinnitus. •A wide variety of drugs have been used off-label to treat tinnitus sufferers, with limited effect. •NMDA (N-methyle-D-aspartate)and AMPA(alpha-amino-3-hydroxy-5-methyle-4-isoxazolepropionic acid) receptors both are ionotropic glutamate receptor subtypes which are present in afferent nerve fibers of inner hair cell are targeted for the therapy of tinnitus. •Caroverine, is a class B calcium-channel-blocker that exhibits competitive AMPA antagonism, and noncompetitive NMDA antagonism. •The pharmacologic effects of Amitriptyline a tricyclic antidepressants-act on various neurotransmitter receptors and endorphin pathways decreases the cochlear potential and decreased production of endolymph.
|