| CTRI Number |
CTRI/2024/11/077332 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating Sinarest Oral Drops for Infants with Common Cold: Safety and Efficacy Study |
|
Scientific Title of Study
|
A multicentric, non-randomized, open label, non-comparative, active post marketing surveillance
(PMS) study to evaluate the safety and efficacy of Sinarest Oral Drops in infants of common cold. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 087-20 version 1.0, dated 20-January-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayuresh Kiran |
| Designation |
Vice President Medical Services and Pharmacovigilance |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near hotel Grand
Hyatt, Vakola, Santacruz (E), Mumbai 400 055
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609156 |
| Fax |
|
| Email |
drmayuresh@centaurlab.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pramita Waghambare |
| Designation |
Executive Pharmacovigilance and Biomedical Reasearch |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near hotel Grand
Hyatt, Vakola, Santacruz (E), Mumbai 400 055
Mumbai (Suburban)
MAHARASHTRA
400055
India |
| Phone |
02267609341 |
| Fax |
|
| Email |
pramita@centaurlab.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aakansha Singh |
| Designation |
Officer Medical Services |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near hotel Grand
Hyatt, Vakola, Santacruz (E), Mumbai 400 055
Mumbai (Suburban)
MAHARASHTRA
400055
India |
| Phone |
02267609341 |
| Fax |
|
| Email |
med_user2@centaurlab.com |
|
|
Source of Monetary or Material Support
|
| Centaur Pharmaceuticals Pvt Ltd, Centaur House, Shanti Nagar, near Grand Hyatt, Vakola,
Santacruz East, Mumbai, Maharashtra 400055 |
|
|
Primary Sponsor
|
| Name |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt Ltd Centaur House, Shanti Nagar, near
Grand Hyatt, Vakola, Santacruz East, Mumbai, Maharashtra 400055 |
| 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 Shivaprakash Sosale |
Arunodaya Children Clinic |
Arunodaya Children Clinic,
No 20/1 Lakshmaiah Complex
T Dasarahalli
Bangalore 560057
Landmark: Near Soundarya Paradise Hotel
Bangalore
KARNATAKA |
7204776479
shivaprakashsosale@gmail.com |
| Dr Sandeep Bhople |
Kilbil Children’s Hospital |
Kilbil Children’s Hospital, 1st And 2nd Floor, Sarvoday Classic Building, Radhanagar, Khadakpada, Kalyan (West)
Thane
MAHARASHTRA |
9619968282
drsandip1903@gmail.com |
| Dr Amit Kumar |
Medicure clinic |
Maurya Path, Near Pillar No.15, Khajpura, Patna, Bihar-800014 Patna BIHAR
Patna
BIHAR
Patna
BIHAR |
7544067738
coolmickeydoc@gmail.com |
| Dr Akshi Singh |
Upendra Medicare |
Upendra Medicare, S4/50-D-4-A, Mahaveer Mandir, Tajpur, Orderly Bazar, Varanasi, Uttar Pradesh, 221001
Varanasi
UTTAR PRADESH |
9555112643
drakshisingh25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Pranav diabetes Center |
Approved |
| Shivnath Hospital Private Limited |
Approved |
| Sri Ram Hospital And Research Centre Pvt. Ltd. |
Approved |
| Suraksha 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 |
Sinarest Oral Drops |
Sinarest Oral Drops is a FDC of
Chlorpheniramine maleate 1
mg, Phenylephrine
Hydrochloride 2.5 mg and
Paracetamol 125 mg per ml
which is indicated for common
cold in infants.
1} Duration of active post
marketing surveillance: 5 Days
2} Guardians of the patient will
be given 10 ml free physician
sample pack of Sinarest Oral
Drops and Will be asked to give
the dose of it to the infant
patients as mentioned below: •
For Age 1-6 months – wt Up to
9.7 kg- dose 0.2 ml tid/ qid • For
Age 7-12 months- wt 6.7 – 11.8 kg-dose 0.2 – 0.4 ml tid/ qid |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age up to 1 year having body weight of up to 11.8 kg
Patients of both genders including male and female.
Patients with a confirmed diagnosis of common cold
Patients whose guardians are ready to sign the informed consent form and can adhere to the protocol.
|
|
| ExclusionCriteria |
| Details |
Patients hypersensitive to the investigational product
Patients with severe Hepatic or Renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in mean total symptom score
2.Percentage Reduction in mean total symptom
score |
Day 1, day 3 and day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
02/12/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Sinarest
Oral Drops is a fixed dose combination of Paracetamol 125 mg, Phenylephrine hydrochloride
2.5 mg and Chlorpheniramine maleate 1 mg per ml which is indicated for the
treatment of common cold. The rationale behind this ‘Active Post-Marketing
Surveillance study’ is to document the efficacy and safety of Sinarest Oral
drops for the treatment of common cold in infants. common cold of viral origin
is a self-limiting disease which usually takes up to 10 days to cure by itself.
Most of the patients suffer from common cold is due to viral infection of page
upper respiratory tract. According to the guidelines of DPHHS and Cochrane
review combination of analgesic, antihistaminic and decongestant medication can
be used for the treatment of common cold. Taking this into consideration we
have proposed Active Post-Marketing Surveillance study of Sinarest Oral Drops
in infants of common cold. |