| CTRI Number |
CTRI/2022/10/046178 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess the Safety and effect of Wikoryl DS oral suspension in children having common cold with fever |
|
Scientific Title of Study
|
A Multi-centric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Wikoryl DS oral suspension in children suffering from common cold associated with fever |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AL-WK-22-003 Version 01 Dated 16/6/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devendra Khandke |
| Designation |
Senior Vice President, Medical Services Dept. |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Alembic Pharmaceuticals Limited,
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East, Mumbai, Maharashtra
Mumbai MAHARASHTRA 400099 India |
| Phone |
9769461291 |
| Fax |
|
| Email |
da.khandke@alembic.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devendra Khandke |
| Designation |
Senior Vice President, Medical Services Dept. |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Alembic Pharmaceuticals Limited,
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East, Mumbai, Maharashtra
Mumbai MAHARASHTRA 400099 India |
| Phone |
9769461291 |
| Fax |
|
| Email |
da.khandke@alembic.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Devendra Khandke |
| Designation |
Senior Vice President, Medical Services Dept. |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Alembic Pharmaceuticals Limited,
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East, Mumbai, Maharashtra
Mumbai MAHARASHTRA 400099 India |
| Phone |
9769461291 |
| Fax |
|
| Email |
da.khandke@alembic.co.in |
|
|
Source of Monetary or Material Support
|
| Alembic Pharmaceuticals Limited, 2nd Floor, Prime Corporate Park Behind ITC Grand Maratha
Sheraton, Sahar Road, Andheri East, Mumbai, Maharashtra 400099 |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreyans Shah |
Aatman Hospital |
Basement, 5, Anveshan
Row House, Bopal
Ghuma Road, Bopal
Ahmadabad Ahmadabad GUJARAT |
9909977831
cr.aatman@gmail.com |
| Dr Mandar Haval |
Jeevan Rekha Hospital |
Research Department,
3rd Floor, Jeevan
Rekha Hospital, Dr. BR
Ambedkar road, Opp
Civil Hospital Belgaum Belgaum KARNATAKA |
7766984722
mandarnhaval@gmail.com |
| Dr Arakhita Swain |
Kanungo Institute of Diabetes Specialities |
Research Room, Kanungo Institute of Diabetes Specialities, 1120, Dumduma Khordha ORISSA |
9437166120
sudeeppatra@yahoo.com |
| Dr Vishal Tripathi |
Rana Hospital |
Research Room, Rana Hospital, Rail Vihar Medical College Road Gorakhpur UTTAR PRADESH |
8700304154
dr.vishaltripathicr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee Rana Hospital Pvt Ltd |
Approved |
| KIDS Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Wikorly DS Oral Suspension |
2.5 ml to 5ml three to four times a day for 5 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 2-12 years of age. (12-40 Kg body weight)
2. Genders Eligible for Study: both Males and Females
3. Patients with clinical diagnosis of common cold associated with fever. These symptoms may include rhinorrhea, nasal congestion, sneezing etc.
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 DS Oral Suspension |
Day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To 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)
|
06/10/2022 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not available yet |
|
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 DS Oral Suspension, FDC of Paracetamol 250 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg and Sodium citrate 60 mg per 5 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 DS Oral suspension . 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). |