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CTRI Number  CTRI/2021/12/039024 [Registered on: 29/12/2021] Trial Registered Prospectively
Last Modified On: 28/12/2021
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 Drops in infants (1 year)  
Scientific Title of Study   A Multicentric, non-randomized, open label, non-comparative, active post marketing surveillance (PMS) to evaluate the safety and efficacy of Wikoryl Oral Drops in infants suffering from Common cold with fever 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AL-WK-21-002 Version 1.0 Dated 8/Dec/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradip N Gore 
Designation  Senior Manager - Medical Services 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East Mumbai

Mumbai
MAHARASHTRA
400099
India 
Phone  9923404398  
Fax    
Email  pradip.gore@alembic.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradip N Gore 
Designation  Senior Manager - Medical Services 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East Mumbai


MAHARASHTRA
400099
India 
Phone  9923404398  
Fax    
Email  pradip.gore@alembic.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pradip N Gore 
Designation  Senior Manager - Medical Services 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East Mumbai


MAHARASHTRA
400099
India 
Phone  9923404398  
Fax    
Email  pradip.gore@alembic.co.in  
 
Source of Monetary or Material Support  
Alembic Pharmaceuticals Ltd. (2nd floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai - 400 099, India 
 
Primary Sponsor  
Name  Alembic Pharmaceuticals Limited 
Address  2nd Floor, Prime Corporate Park Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri East, Mumbai, Maharashtra 400099 
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 Abhishek T Chavan  Jeevan Rekha Hospital  Research Department, 3rd Floor, Jeevan Rekha Hospital, Dr. BR Ambedkar road, Opp Civil Hospita
Belgaum
KARNATAKA 
9113222185

dr.abhishektchavan@gmail.com 
Dr V N Tripathi   Prakhar Hospital Pvt. Ltd.  Clinical Research Department, 4th Floor, Prakhar Hospital, 8/219, Arya Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH 
9415050777

dr.vntripathicr@gmail.com 
Dr Madhav Pandya   SMVS Swaminarayan Hospital  Gandhinagar-Ahmedab ad Road, Besides Swaminarayan Dham
Gandhinagar
GUJARAT 
9662203454

drmadhavcr@gmail.com 
Dr Rajib Ray  Sparsh Hospital and Critical care  Research Room, Ground Floor, Sparsh Hospitals and Critical Care (P) Ltd, A/407, Sahid Nagar, Bhubaneshwar
Khordha
ORISSA 
8249771669

drrajib207@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee of Prakhar Hospital  Approved 
Institutional Ethics Committee Jeevan Rekha Hospital  Approved 
Institutional Ethics Committee Sparsh Hosital  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  FDC of Paracetamol 125 mg, Phenylephrine Hydrochloride 2.5 mg and Chlorpheniramine Maleate 1 mg per ml  10-20 drops three times a day for 5 days 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  1.00 Year(s)
Gender  Both 
Details  1. Age: up to 1 year (weight: 2.5-12 kg)
2. Genders Eligible for Study: both Males and Females
3. Patients with confirmed clinical diagnosis of Common cold with fever
4. Patients whose guardians 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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of Wikoryl Oral Drops  Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Change in symptom scores for fever, rhinorrhea,
nasal congestion and sneezing 
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)   05/01/2022 
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="2"
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 Wikoryl Oral Drops, FDC of Paracetamol 125 mg, Phenylephrine Hydrochloride 2.5 mg, Chlorpheniramine Maleate 1 mg, per 1 ml in children suffering from Common cold with fever. The active PMS will be conducted for the duration of 5 days by the investigator. At day 1 (baseline) the patient’s guardian 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 Oral Drops. Based on the prescription of the principle investigator the guardians of the patient will give the patient the required medication for the period of 5 days starting from day 1 (visit 1). Also patient’s guardians will be asked to visit to the clinical trial site along with the patient at day 6 for safety and efficacy assessment. Symptom assessment at baseline and visit 2, will be done by principle investigator by measuring the symptom scores for fever, rhinorrhea, nasal congestion and sneezing on a four-point Likert scale for intensity (severity): 0= no symptom, 1 = mild, 2= moderate and 3= severe. Fever is characterized as 0= No fever (< 100.4), 1=Mild/low-grade fever (100.5–102.2 F) ,2=Moderate grade fever (102.2–104.0 F), 3= High grade fever High-grade (104.1–106.0 F).
 
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