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CTRI Number  CTRI/2022/04/042134 [Registered on: 25/04/2022] Trial Registered Prospectively
Last Modified On: 20/04/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Post marketing study to evaluate the Safety and Efficacy of Wikoryl tablets in adult patients 
Scientific Title of Study   A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Alembic Wikoryl tablets in adults suffering from common cold 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AL-WK-22-002; Version 01; dated 10/Feb/22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devendra Khandke 
Designation  Senior Vice President, Medical Services Dept. 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400099
India 
Phone  9769461291  
Fax    
Email  da.khandke@alembic.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Devendra Khandke 
Designation  Senior Vice President, Medical Services Dept. 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East, Mumbai, Maharashtra


MAHARASHTRA
400099
India 
Phone  9769461291  
Fax    
Email  da.khandke@alembic.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Devendra Khandke 
Designation  Senior Vice President, Medical Services Dept. 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East, Mumbai, Maharashtra


MAHARASHTRA
400099
India 
Phone  9769461291  
Fax    
Email  da.khandke@alembic.co.in  
 
Source of Monetary or Material Support  
Alembic Pharmaceuticals Limited, Corporate office, Alembic City, Alembic Rd, Gorwa, Vadodara, Gujarat  
 
Primary Sponsor  
Name  Alembic Pharmaceuticals Ltd 
Address  Corporate office, Alembic City, Alembic Rd, Gorwa, Vadodara, Gujarat 390003 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suresh Bhate  Jeevan Rekha Hospital  Clinical Research Room , 3rd Floor, Jeevan Rekha Hospital, Dr. BR Ambedkar road, Opp Civil Hospital Belgaum
Belgaum
KARNATAKA 		 9380840560

drsureshgbhate@gmail.com 
Dr Prabhat Kumar Sharma  Maharaja Agrasen Superspeciality Hospital  Clinical Research room, Basement, Maharaja Agrasen Hospital, Central Spine, Agrasen Aspatal Marg , Sector-7 Vidyadhar Nagar
Jaipur
RAJASTHAN 		 9983995050

pksharma.clinical@gmail.com 
Dr Maulita Kapadiya  SMVS Swaminarayan Hospital  Medicine OPD, Ground Floor, SMVS Hospital, Gandhinagar-Ahmedabad Road, Besides Swaminarayan Dham
Gandhinagar
GUJARAT 		 7016097684

drmaulitacr@gmail.com 
Dr Sunil Madhab Panda  Sparsh Hospital and Critical care  clinical Research room, ground Floor, Sparsh Hospital & Critical Care, A/407 Back Side Of Kalyan Jewellers, Saheed Nagar
Khordha
ORISSA 		 9437217225

sudeeppatra@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Jeevan Rekha Hospital  Approved 
Institutional Ethics Committee Sparsh Hosital  Approved 
Institutional Ethics Committee (IEC), Maharaja Agrasen Superspecialty Hospital  Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alembic Wikoryl tablets, FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg in each table  1 tablet, 3 to 4 times in a day for 5 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients with confirmed clinical diagnosis of common cold
2. Patients who can adhere to the Protocol
 
 
ExclusionCriteria 
Details  1. Patients known to be hypersensitive to investigational product
2. Patients with severe Hepatic or Renal dysfunction
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of Alembic Wikoryl tablets  Baseline (Day 1) and Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Change in symptom scores for fever, rhinorrhea,
nasal congestion and sneezing (Rated on 4 point
scale 0-3) 		 Baseline and Day 6 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   26/04/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
It will be a Multicentric, Non-Randomized, Open label, Non-Comparative, Active PMS to evaluate the Safety and Efficacy of Alembic Wikoryl tablets (fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg) in adults suffering from Common cold. The study will be conducted at 4-6 specialty sites and at each site 40-60 adults will be recruited as per the inclusion and exclusion criteria by the investigator. The active PMS will be conducted for the duration of 5 days by the investigator. At day 1 (baseline) the patient will be informed about the study procedure and if agreed then his/ her sign on the informed consent form will be taken and patient will be recruited for the active PMS of Wikoryl 10 tablets. Based on the prescription of the principle investigator the patient will take the required medication in the dose of 1 tablet, 3 to 4 times in a day or as directed by investigator for the period of 5 days starting from Day 1 (Visit 1). Also patient will be asked to visit to the clinical trial site at day 6 for safety and efficacy assessment.
 
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