| 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
|
|
|
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
|
|
|
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 |
|
|
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 |