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CTRI Number  CTRI/2024/10/075430 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of safety and Effectiveness Oral Prochlorperazine in patients diagnosed with acute phase of Benign Paroxysmal Positional Vertigo (BPPV) 
Scientific Title of Study   A Multi-Centric, Prospective, Single Arm, Open label Post Marketing Observational Study To Assess The Effectiveness And Safety Of Oral Prochlorperazine In Acute Phase In Patients Diagnosed With Benign Paroxysmal Positional Vertigo (BPPV). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PROC-524-0469, V 1.0; 12-Jun-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudipta Chandra 
Designation  Principal Investigator  
Affiliation  PURNAM MEDICARE 
Address  Purnam Medicare 5/1, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700002

Kolkata
WEST BENGAL
700002
India 
Phone  9830640314  
Fax    
Email  scdr60@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kartik Peethambran 
Designation  Associate Director - Medical Affairs 
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East, Mumbai-400051

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  912250462305  
Fax    
Email  kartik.peethambaran@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Director Clinical Development & Operations 
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East, Mumbai-400051

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  912250460456  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Private Limited, Floor 18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East, Mumbai-400051, Maharashtra, India 
 
Primary Sponsor  
Name  Abbott Healthcare Private Limited 
Address  Floor 18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East, Mumbai-400051, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jasveer Singh  ENT and Shape Your Nose Clinic  D3, near Kailash Hospital, D Block, Pocket D, Sector 20, Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9891272427

asianjasveer@gmail.com 
Dr H Ramesh  Government Medical College Srikakulam   Department of ENT, 1st Ward, Balaga, Srikakulam Town, Srikakulam Dist. Andhra Pradesh – 532001
Srikakulam
ANDHRA PRADESH 		 9912320517

muralidhargudla@yahoo.com 
Dr Mangesh Patil  Medipoint Hospitals Pvt. Ltd.  Medipoint Hospitals Pvt. Ltd. 241/1, New D. P. Road, Aundh, Pune-411007, Maharashtra, INDIA.
Pune
MAHARASHTRA 		 9922441255

drmangeshpatil.medipoint@gmail.com  
Dr Sudipta Chandra  PURNAM MEDICARE  5/1, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 70002
Kolkata
WEST BENGAL 		 9830640314

scdr60@gmail.com 
Dr Neha Srivastava  RTKL VERTIGO & ENT CLINIC  BUNGALOW NO.5,DHEERAJ SAVERA,OPP SIDDHARTH NAGAR, NEXT TO BMC PARK,BORIVALI EAST, Mumbai, Maharashtra 400066
Mumbai (Suburban)
MAHARASHTRA 		 9833109195

rtklvertigoandentclinic@gmail.com 
Dr Gayatri Pandit  Samarth ENT and Allergy Centre  12, Shree Plaza Kothnur Dinne Main Road, Nrupathunga Nagar, JP Nagar 7th Phase, Kothnur, Bengaluru, Karnataka 560078
Bangalore
KARNATAKA 		 9886758980

drgayatripandit@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinimed Independent Ethics Committee  Approved 
Genebandhu Independent Ethics Committee   Approved 
IEC GMC and GGH Srikakulam  Approved 
Penta-Med Ethics Committee  Approved 
Sri Durgamba Independent Ethics Committee  Approved 
Suraksha – Ethics Committee  Approved 
Suraksha – Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H811||Benign paroxysmal vertigo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Prochlorperazine Maleate 5 mg - Mouth Dissolving Tablet   In this study patients will be prescribed Prochlorperazine 5mg tablet TID, for a period of 3 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female patients in the age group of ≥18 to ≤65 years, with confirmed diagnosis of BPPV and prescribed prochlorperazine for acute phase by treating physician as per approved label.
2. The patient who has read the informed consent form and 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.
 
 
ExclusionCriteria 
Details  1. Patients on prochlorperazine or any other anti-vertigo therapy drugs in the past 15 days.
2. Patients with a history of psychiatric illness or on anti-psychotic or anti-depressant medication in the past 6 months.
3. Patients with a history of cardiovascular, kidney, or liver disorders.
4. Patients with suspected or established subcortical brain damage, with or without hypothalamic damage.
5. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating.
6. Patients with a known history of hypersensitivity to phenothiazine derivatives.
7. Participants in any clinical trial in past 30 days before enrolment.
8. Patients with a history of any malignancy.
9. Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator or those requiring hospitalization for any cause.
10. Patients who are on concomitant medications such as anticholinergics, barbiturates, beta-blockers, cisapride, sparfloxacin, guanethidine, Metrizamide, Paroxetine, antihypertensives.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of prochlorperazine 5mg Tablet in the acute phase in patients diagnosed with BPPV.  Day 1 and 4 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness 1. To assess improvement in the severity of vertigo-associated symptoms (Anxiety, Headache, and Nausea/ Vomiting) post-treatment with prochlorperazine 5mg tablet Safety 1. To evaluate the safety and tolerability of treatment with prochlorperazine 5mg tablet in the Indian adult population with BPPV.  Day 1 and 4 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) 19/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   This is a prospective, multicenter, single-arm, open-label, post-marketing observational study designed to evaluate the effectiveness and safety of prochlorperazine 5mg tablet in the management of BPPV in patients in the age group of ≥18 to ≤65 years. This multicenter study will enroll approximately 300 adult patients with BPPV. The patients will be followed up for 3-days after enrollment into the study. The enrollment of patients for the study will be based on the approved protocol by the local ethics committee. All the patients with a clinical diagnosis of BPPV, meeting all inclusion and none of the exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this observational study. The study is planned to be conducted for approximately 8 months. 
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