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CTRI Number  CTRI/2021/02/031189 [Registered on: 10/02/2021] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A post-marketing study of the marketed product Maxtra® P syrup for the evaluation of safety and effects in children having common cold. 
Scientific Title of Study   An active post marketing surveillance to evaluate the safety and efficacy of a fixed-dose combination of Paracetamol 125mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 1mg per 5mL syrup in symptomatic treatment of common cold in children.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZUV/FDC/COLD-SYRUP/2017, Ver: 2.0, Date: 14 January 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhupesh Dewan 
Designation  Director, Medical Services 
Affiliation  Zuventus Healthcare Limited 
Address  Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E)

Mumbai
MAHARASHTRA
400072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhupesh Dewan 
Designation  Director, Medical Services 
Affiliation  Zuventus Healthcare Limited 
Address  Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E)


MAHARASHTRA
400072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhupesh Dewan 
Designation  Director, Medical Services 
Affiliation  Zuventus Healthcare Limited 
Address  Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E)


MAHARASHTRA
400072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Source of Monetary or Material Support  
Zuventus Healthcare Limited, 5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E),Mumbai- 400072 
 
Primary Sponsor  
Name  Zuventus Healthcare Limited 
Address  5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E),Mumbai- 400072 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyotsna Seepana  Government Medical College and Government General Hospital  OPD No 14, 1st floor, Department of Pediatrics, Srikakulam 532 001, Andhra Pradesh
Srikakulam
ANDHRA PRADESH 		 8942279033

drjyotsnaggh@yahoo.com 
Dr Kalpana Dutta  Healthpoint Hospital  Room no.12, Clinical research room, OPD building, Opp Lansdown Padmakupur, 21 Pranath Pandit Street Kolkata. 700025
Kolkata
WEST BENGAL 		 9836391694

drkalpana1975@gmail.com 
Dr Ashish Dhongade  Sant Dynaneshwar Medical Research centre  695/A, Department of Paediatric, Sadashiv Peth, Opposite Vijay Talkies, Laxmi Road, Pune 411030
Pune
MAHARASHTRA 		 9011095436

adhongade1@gmail.com 
Dr Neeraj Kumar  Sarojini Naidu Medical College  Department of Pediatrics, Ground Floor, Sarojini Naidu Medical College, Moti Katara, Agra, Uttar Pradesh - 282003
Agra
UTTAR PRADESH 		 9410406920

neerajyadu@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Health Point Ethics Committee  Approved 
IEC Govt. Medical College Govt. Gen Hospital, Srikakulam  Approved 
IEC Sant Dnyaneshwar Medical Education Research Centre  Approved 
IEC, S N Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Maxtra P Syrup [Fixed dose combination (FDC) of Paracetamol 125mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 1 mg per 5ml syrup)  For patients in 6 to 11 years of age group: 5 ml syrup to be administered every 4 to 6 hours orally for 5 days. For patients in ≥ 12 to 18 years of age group: 10 ml of syrup to be given every 4 to 6 hours orally for 5 days. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1. Patients ≥6 years to <18 years of age
2. Patients with symptoms of common cold of recent onset, for more
than 6 hours and less than 72 hours.
3. Children who give assent to participate in the study (For participants
between 6 & 12 years, verbal assent is admissible in presence of their
parents / Legally Acceptable Representative (LAR). Participants aged
between 12 & 18 years should personally sign and date a separately
designed, written assent form.) 
 
ExclusionCriteria 
Details  1. Hypersensitivity to any of the ingredients of the formulation.
2. Patients with hepatocellular insufficiency and in patients with hepatic
failure or active liver disease.
3. Patients who took an antihistamine, analgesic or decongestant 1 day
prior to study enrollment.
4. Patients otherwise judged to be inappropriate for inclusion in the
study by the investigator 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients reporting adverse events during the study
period.
2. Assessment of therapy by investigators and patients at the end
of the study period. 		 Day 0 and Day 5 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of patients experiencing reduction in severity of
symptoms.
2. Proportion of patients with complete remission. 		 Day 0 and Day 5 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   12/02/2021 
Date of Study Completion (India) 03/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Common cold is the most frequently encountered disease in medical practice. It is commonly recognized by a group of symptoms such as sore throat, rhinorrhoea,nasal congestion, coughing, low grade fever, headaches and malaise. Over the counter and flu medicines are the main stay of treatment and aim towards symptomatic relief. It has been found in published literature that the anithistamineanalgesic-decongestant combinations have general benefit in reducing the duration and alleviating the symptoms of common cold. Therefore, combination of Chlorpheniramine maleate (Antihistamine), Paracetamol (Analgesic) and Phenylephrine hydrochloride (decongestant) is an appropriate combination for alleviating symptoms of cold, rhinitis and other upper respiratory tract allergies.
 
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