FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100540 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Studying How Safe and Effective Mefenamic Acid Is for Treating Fever in Indian Children. 
Scientific Title of Study   An Observational Study on the Safety and Effectiveness of Mefenamic Acid in Paediatric Patients with Febrile Illness: Real World Evidence in Indian Paediatric Settings (ASSESS-MAPP) 
Trial Acronym  ASSESS-MAPP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uday Pai 
Designation  Paediatrician  
Affiliation  AANGAN Clinic 
Address  301 Glamcent Central Avenue Road Chembur East Mumbai 400071

Mumbai
MAHARASHTRA
400071
India 
Phone  9820060171  
Fax    
Email  Drudayapai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Uday Pai 
Designation  Paediatrician  
Affiliation  AANGAN Clinic 
Address  301 Glamcent Central Avenue Road Chembur East Mumbai 400071

Mumbai
MAHARASHTRA
400071
India 
Phone  9820060171  
Fax    
Email  Drudayapai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Uday Pai 
Designation  Paediatrician  
Affiliation  AANGAN Clinic 
Address  301 Glamcent Central Avenue Road Chembur East Mumbai 400071

Mumbai
MAHARASHTRA
400071
India 
Phone  9820060171  
Fax    
Email  Drudayapai@gmail.com  
 
Source of Monetary or Material Support  
Blue Cross Laboratories Pvt Ltd Peninsula Corporate Park Peninsula Chambers GK Marg Lower Parel Mumbai 400 013 India 
 
Primary Sponsor  
Name  Blue Cross Laboratories Pvt Ltd 
Address  Peninsula Corporate Park Peninsula Chambers GK Marg Lower Parel Mumbai 400 013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uday Pai  AANGAN Clinic  301 Glamcent Central Avenue Road Chembur East Mumbai 400071
Mumbai
MAHARASHTRA 
9820060171

Drudayapai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Care Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R509||Fever, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Paediatric individuals presenting with fever greater than or equal to 99.5 degree F

The patient is being managed on an outpatient basis without requiring hospital admission at the time of enrollment

The patient receiving mefenamic acid as an antipyretic treatment and other concomitant medications prescribed will be captured

Patient or LAR agreed to provide written informed consent 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the clinical effectiveness and tolerability of mefenamic acid in the management of fever among paediatric outpatients  Temperature record at 0 min 15 minute 30 minute 45 minute 1 hr 2 hr 4 hr 6 hr and 8 hr

All adverse events occurring during the study will be carefully documented throughout the study 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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   N/A 
Date of First Enrollment (India)   19/01/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
This prospective multicentre observational study is designed to evaluate the effectiveness and tolerability of mefenamic acid in paediatric outpatient settings. A total of 150 practicing paediatricians each qualified with MBBS and MD Paediatrics DNB Paediatrics or DCH will participate in the study. These 150 paediatricians will enroll 10 patients each at their outpatient department, resulting in a total of 1500 paediatric patients. Eligible participants will be children aged between six months and twelve years presenting with fever greater than 99.5 degree F managed on an outpatient basis with mefenamic acid. Digital informed consent will be obtained from the parent or legally acceptable representative prior to any data collection to ensure ethical compliance.
Effectiveness will be assessed by calculating the area under the curve of the percent reduction in fever from baseline across multiple time points, including 0 minutes 15 minutes 30 minutes 45 minutes 1 hour 2 hours 4 hours 6 hours and 8 hours. In addition the treating paediatrician’s clinical judgment will be used to evaluate both effectiveness and tolerability. All adverse events observed during the study will be carefully documented in electronic case report forms capturing details such as the nature severity duration and any medical or procedural actions taken. This structured approach aims to provide comprehensive insights into the clinical utility and safety profile of mefenamic acid in routine paediatric practice
 
Close