CTRI/2022/01/039287 [Registered on: 10/01/2022] Trial Registered Prospectively
Last Modified On:
05/10/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Other (Specify) [Post Marketing Study]
Study Design
Single Arm Study
Public Title of Study
Post Marketing Observational Study to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo
Scientific Title of Study
A Prospective, Multicenter, Open-Label, Single-Arm, Post Marketing Observational Study
to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
PROC-521-0124, Version 1.0 dated 22-Nov-2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mohan Kameswaran
Designation
Prof Dept of ENT
Affiliation
Madras ENT Research Foundation
Address
Madras ENT Research Foundation, No-1, I Cross Street, Off. II Main Road, Raja Annamalaipuram, Chennai – 600 028.
Chennai TAMIL NADU 600 028 India
Phone
9840733366
Fax
Email
merfmk30@yahoo.com
Details of Contact Person Scientific Query
Name
Dr Anuja Jawale
Designation
Affiliate Safety Representative
Affiliation
Abbott Healthcare Pvt. Ltd.
Address
Abbott Healthcare Pvt Ltd
Floor 16, Godrej BKC,
Plot No C – 68, BKC, Near MCA Club,
Bandra (E) Mumbai
Mumbai MAHARASHTRA 400051 India
Phone
8657459168
Fax
Email
anuja.sawant1@abbott.com
Details of Contact Person Public Query
Name
Vairamuthu Ammaiyappan
Designation
Director-Bussiness Expansion and Clinical Research
Affiliation
IDD Research Solutions
Address
Tek Meadows Campus,No 51, 3rd, C block, Old Mahabalipuram Rd, Sholinganallur, Chennai, Tamil Nadu
Agrawal Nursing Home, First floor, Central Avenue, Gandhi Putala, Nagpur-440002
Nagpur MAHARASHTRA
9823164283
dr.sandipagrawal@rediffmail.com
Dr C Preetam
AIIMS
Department of ENT and Head & Neck Surgery,AIIMS Bhubaneswar, Sijva, patrapad, Bhubaneshwar 751019
Khordha ORISSA
9438884166
preetam82@gmail.com
Dr Anand Raju
Anand ENT Hospital
1st Floor,39-42,Sarojini Naidu Road,Balaji Nagar,new Siddhatuputur,Coimabatore-641044 Coimbatore TAMIL NADU
9842996596
ranandent@yahoo.com
Dr Sanika Kalambe Ghate
Dr. Sanika ENT Clinic
Dr. Sanika ENT Clinic, G-1, Second floor, Near Dharmpeth Mahila Bank, Mokha Towers , Trimurthi Nagar, Ring Road, Nagpur- 440022
Nagpur MAHARASHTRA
9284417019
govindap.2208@gmail.com
Dr Shweta Gogia
Dr. Shweta Gogia ENT Clinic
F77 1st Floor, Old building, Near sai Gangaram hospital Delhi 110060
New Delhi DELHI
9818966277
drshwetagogia@gmail.com
Dr Pravahar Chilluveru
Excel Hopsital
1-5-56/29, Department of ENT, First floor, Room no 101, Old Alwal Road, Beside Bharat Petroleum Near IG Statue, Banda Basti, Secundarabad, Telangana 500010
Hyderabad TELANGANA
9440664042
doctorresearch1212@gmail.com
Dr Tushar Kanti Ghosh
Ghosh ENT Foundation
GD- market, FE350,First Floor, FE Block lane, Sector III, Kolkata- 700106 , West Bengal Kolkata WEST BENGAL
9830196537
tusharghish_kolkata@yahoo.com
Dr Harendra Kumar
GSVM Medical College
GSVM Medical College, Second Floor, Swaroop Nagar Kanpur-208002
Kanpur Nagar UTTAR PRADESH
9695334616
harendragautam34@yahoo.in
Dr Ankur Kumar
Infinia Dental and ENT Clinic
81 Raja Rammohan Roy Sarani,First Floor, Amherst St, Kolkata, West Bengal 700009 Kolkata WEST BENGAL
7760621864
drankur86@gmail.com
Dr MB Bharathi
JSS Hospital
Room no 1058,Ground Floor,Department of ENT,JSS Hospital, Mahatma Gandhi Road, Ramchandra Agarahara, Mysuru-570004
Mysore KARNATAKA
1st Floor, ENT Clinic,Krishna Maternity Home, 730, Near Canada Corner Signal, Umiya Apt, above ICICI Bank, Nashik, Maharashtra 422002
Nashik MAHARASHTRA
7058990690
clinicalselite@gmail.com
Dr Mohan Kameswaran
Madras ENT Research Foundation
Ground floor,ENT department,ENT Research Foundation, No-1, I Cross Street, Off. II Main Road, Raja Annamalaipuram, Chennai – 600 028. Chennai TAMIL NADU
919633648748
vandana.aravind217@gmail.com
Dr Vineet Jain
Mahavir ENT Hopsital
Mahavir ENT Hopsital, First Floor, 8-A-4, Mahavir Nagar, Kota 324006
Kota RAJASTHAN
8766120071
narendrasinghal007@gmail.com
Dr Minal Modi
Modi Clinic
Ground floor,ENT clinic,Modi Clinic, 61A, Raksha Lekha Society, Pune - Satara Road, Dhankawadi, Pune, Maharashtra 411043
Pune MAHARASHTRA
9890361917
modiminal@yahoo.co.in
Dr Alok Agarwal
Nidanta Superspeciality Clinic
5/19 Ground Floor East Patel Nagar New Delhi
New Delhi DELHI
9811211669
alokagarwal.ent@gmail.com
Dr Gautam Khaund
Nightingale Hospital
Room No 1,Ground Floor,Department of ENT,Nightingale Hospital, Shillong Road, Dispur, Guwahati - 781005,
Kamrup ASSAM
9864062999
gautamkhaund@rediffmail.com
DrSudipta Chandra
Purnam Medicare
Ground Floor,5/1,AGC Boss road,Kolkata-700020 Kolkata WEST BENGAL
9830640314
scdr60@gmail.com
Dr Harikrishna Reddy
Ramya Hospital
Plot No.8,9,10 414/50, Second Floor, Main Road, Old Bowenpally Cross Rd, Secunderabad, Telangana 500011
Hyderabad TELANGANA
9440664042
drresearch1212@gmail.com
Dr Bimal Kumar Mandal
RD ENT clinic
3E,First Floor, Mansatala Row, Khidirpur, Kolkata, West Bengal 700023
Kolkata WEST BENGAL
6291550961
nabina@valnizen.com
Dr Gayatri Pandit
Samarth ENT Clinic
Shop No.4 and 5,Mazzainine Floor, shree plaza, Kothnur Main Rd, Opposite Mithai Mane, Nrupathunga Nagar, JP Nagar 7th Phase, J. P. Nagar, Bengaluru, Karnataka 560078
Bangalore KARNATAKA
9886758980
drgayatripandit@gmail.com
Dr KGSomashekara
Saptgiri Institute of Medical Sciences
Ground Floor,ENT Department,15, Hesarghatta Main Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore KARNATAKA
9844024597
somashekara.kganesh@gmail.com
Dr Maheshkumar Nikam
Shreepad Ent Hospital
Shreepad Ent Hospital, F/14 First Floor, Surya Arcade, Panchavati, Nashik - 422003 Nashik MAHARASHTRA
Institutional Ethics Committee JSS Medical College
Approved
Institutional Ethics Committee, Bhubaneswar
Approved
KIMS Institutional Ethics Committee
Approved
Medstar Speciality Hospital Ethics Committee
Approved
MERF Institute of Ethical Committee
Approved
Muktai Hospital Institutional Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Saptgiri Institute of Medical sciences and Research centre, Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: G939||Disorder of brain, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either sex in the age group of 18-65 years.
2. Patients diagnosed with Meniere’s disease, vestibular neuritis, labyrinthitis, or
post-operative vertigo.
3. Patients willing to participate in the study and sign an informed consent form
ExclusionCriteria
Details
1. Patients diagnosed with BPPV.
2. Patients with history of psychiatric illness.
3. Patients on anti-psychotic or anti-depressant medication.
4. Patients with history of cardiovascular, kidney or liver disorder.
5. Patients requiring hospitalization for any cause.
6. Patients with suspected or established subcortical brain damage, with or without
hypothalamic damage.
7. Pregnant and nursing women.
8. Women with childbearing potential who are not practicing a reliable method of birth
control.
9. Patients with a known history of hypersensitivity to phenothiazine derivatives
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing
clinical response based on the scale for vestibular vertigo severity level and clinical
response evaluation (SVVSLCRE), from baseline to post-treatment
Visit1 to Visit 5
Secondary Outcome
Outcome
TimePoints
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing
change in the severity of vertigo symptoms through improvement in nystagmus grading,
from baseline to post-treatment.
2. Safety and tolerability:
a) To evaluate the safety of prochlorperazine, in acute vertigo patients, from baseline to
end of study.
b) To evaluate the tolerability of prochlorperazine, in acute vertigo patients, posttreatment.
3. To evaluate relief in vertigo-associated symptoms, in acute vertigo patients, from
baseline to post-treatment.
Visit 1 to Visit 5
Target Sample Size
Total Sample Size="1708" Sample Size from India="1708" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"