| CTRI Number |
CTRI/2022/03/041002 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
08/03/2022 |
| 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 assess the Safety and Efficacy of Wikoryl 10 tablets in adults suffering from common cold |
|
Scientific Title of Study
|
A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Wikoryl 10 tablets in adults suffering from common cold |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AL-WK-22-001; Version 01; dated 10/Feb/22 |
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 400099
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 400099
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 400099
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 Chintan Patel |
Aatman Hospital |
Basement, 5, Anveshan Row House, Bopal Ghuma Road, Bopal
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Anup Kumar Budhia |
Hi Tech Medical College |
Dept. of General Medicine, Hi-Tech Medical
College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar
Khordha
ORISSA |
7008723962
anup.budhia@gmail.com |
| Dr Amit S Bhate |
Jeevan Rekha Hospital |
Research Department, 3rd Floor, Jeevan Rekha Hospital, Dr. BR Ambedkar road, Opp Civil Hospital
Belgaum
Belgaum
KARNATAKA |
9155661151
jrhclinicalresearchbelgaum@gmail.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Superspeciality Hospital |
Central Spine, Agrasen Aspatal Marg, Sector7, Vidhyadhar Nagar, Jaipur
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@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 (IEC), Maharaja Agrasen Superspecialty Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee Hi tech Medical College and 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 |
FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, Chlorpheniramine Maleate 2 mg |
1 tablet, 3 to 4 times a day for 5 days |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: > 18 years
2. Genders Eligible for Study: both Males and Females
3. Patients with confirmed clinical diagnosis of common cold
4. Patients who 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 10 tablets |
upto Day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in symptom scores for fever, rhinorrhea,
nasal congestion and sneezing (Rated on 4 point scale 0-3) |
Baseline and 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)
|
16/03/2022 |
| 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
|
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 10 tablets
(fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10
mg, Chlorpheniramine Maleate 2 mg) in adults suffering from Common cold. The
study will be conducted at 4-6 specialty sites and at each site 40-60 adults
will be recruited as per the inclusion and exclusion criteria by the
investigator. The active PMS will be conducted for the duration of 5 days by
the investigator. At day 1 (baseline) the patient 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 10 tablets.
Based on the prescription of the principle investigator the patient will take
the required medication in the dose of 1 tablet, 3 to 4 times in a day or as
directed by investigator for the period of 5 days starting from Day 1 (Visit
1). Also patient will be asked to visit to the clinical trial site at day 6 for
safety and efficacy assessment. |