| CTRI Number |
CTRI/2025/10/095854 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out how well a new combination of Paracetamol, Phenylephrine, and Chlorpheniramine works and how safe it is in adults suffering from common cold |
|
Scientific Title of Study
|
A Prospective, Randomized, Assessor-Blinded, Real-world Study to Evaluate the effectiveness and safety of advanced Formulation of FDC of Paracetamol IP 500 mg, Phenylephrine Hydrochloride IP 10 mg, and Chlorpheniramine Maleate IP 2 mg in Adults with Common Cold. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IN-25-02 Version 01 Dated 25 AUG 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297/301, SoBo Center, South Bopal, ahmedabad.
Ahmadabad
GUJARAT
380058
India |
| Phone |
07600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Anil Trailokya |
| Designation |
Sr. GM Medical Services |
| Affiliation |
Indoco House, 166 CST Road, Santacruz (E) |
| Address |
Indoco House, 166 CST Road, Santacruz (E)
Mumbai
MAHARASHTRA
400098
India |
| Phone |
8080042460 |
| Fax |
|
| Email |
abhijit.trailokya@indoco.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit Anil Trailokya |
| Designation |
Sr. GM Medical Services |
| Affiliation |
Indoco House, 166 CST Road, Santacruz (E) |
| Address |
Indoco House, 166 CST Road, Santacruz (E)
Mumbai
MAHARASHTRA
400098
India |
| Phone |
8080042460 |
| Fax |
|
| Email |
abhijit.trailokya@indoco.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indoco Remedies Limited |
| Address |
Indoco House, 166 CST Road, Santacruz (E), Mumbai 400 098, INDIA |
| 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 Chintan Patel |
Aatman Hospital |
Basement , Clinical Research Department,5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal -
Ahmadabad
GUJARAT |
9825182251
drchintan.cr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advanced Formulation of FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet |
Take one tablet thrice daily of advanced Formulation of FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet for 5 days |
| Comparator Agent |
Conventional Formulation FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg |
Take one tablet thrice daily of Conventional Formulation FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet for 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18 to 60 years
2.Patients with Modified Jacksons Score of greater than 6 at screening.
3.Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours.
4.Willing to use effective contraception during the study period (if applicable).
5.Willing and able to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Allergy to any study medication
2.History of asthma, sinusitis, or chronic respiratory disorders
3.Recent use of cold or allergy medications (less than 24 hours)
4.Participation in another clinical trial within the past 30 days.
5.Any condition that, in the investigators judgment, may compromise safety, compliance, or study integrity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in modified Jackson’s score |
At Day 3 and 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first noticeable relief after using study Drug |
Day 0 to Day 5 |
| Patient Satisfaction Score |
At Day 3 and 5. |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drug |
Day 0 to Day 5 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/10/2025 |
| 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
|
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,
randomized, assessor-blinded, real-world study designed to evaluate the
effectiveness and safety of an advanced formulation FDC of Paracetamol IP 500
mg, Phenylephrine Hydrochloride IP 10 mg, and Chlorpheniramine Maleate IP 2 mg
in adults with common cold. The study will enroll adults aged 18 to 60 years
with a Modified Jackson’s Score of >6 at screening and symptoms of common
cold of recent onset, lasting more than 6 hours and less than 72 hours.
Eligible participants will be randomized at baseline (Day 0) to receive either
the test product (advanced formulation) FDC of Paracetamol 500 mg,
Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet, or
the reference product (conventional formulation) FDC of Paracetamol 500 mg,
Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet.
The primary objective is to compare the efficacy of the advanced formulation
versus the conventional formulation FDC, with the primary endpoint being the
change from baseline in Modified Jackson’s Score on Day 3 and Day 5. Secondary
objectives include comparing safety between the two formulations, assessing
time to first noticeable relief, evaluating patient satisfaction on Day 3 and
Day 5, and recording the incidence of adverse events (AEs) and serious adverse
events (SAEs) related to the study drug. |