| CTRI Number |
CTRI/2024/11/077305 [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
|
Active post marketing surveillance study to evaluate the safety and efficacy of Sinarest Syrup in children
with common cold |
|
Scientific Title of Study
|
A multicentric, non-randomized, open label, non-comparative, active post marketing surveillance study to
evaluate the safety and efficacy of Sinarest Syrup in children with common cold |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 089-20 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 House, Near Grand Hyatt, Vakola, Santacruz – East,
Mumbai – 400 055,MAHARASHTRA, India
Mumbai (Suburban)
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 House, Near Grand Hyatt, Vakola, Santacruz – East,
Mumbai – 400 055,MAHARASHTRA, India
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 House, Near Grand Hyatt, Vakola, Santacruz – East,
Mumbai – 400 055,MAHARASHTRA, India
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 House, Near Grand Hyatt, Vakola ,Santacruz – East,
Mumbai – 400 055, India Mumbai (Suburban) MAHARASHTRA
400055 India. |
| 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 Shivprakash 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) MUMBAI.
Mumbai
MAHARASHTRA |
9619968282
drsandip1903@gmail.com |
| Dr Amit Kumar |
Medicure clinic |
Maurya Path, Near Pillar No.15, Khajpura, Patna, Bihar-800014
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 Ethics Committee |
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 syrup |
Sinarest syrup is a FDC of
Paracetamol 125 mg,
Phenylephrine Hydrochloride 5
mg, Chlorpheniramine Maleate
1 mg, Sodium citrate 60 mg and
mentholated flavoured syrupy
base q.s. per 5 ml which is
indicated in children suffering from common cold. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 2 to 12 years having body weight 6 to 40 kg
Patients of either sex (male or female)
Patients with a confirmed diagnosis of common cold
Patients and guardians who are ready to adhere to the protocol
|
|
| ExclusionCriteria |
| Details |
Patients who are known to be 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 |
Reduction in mean total symptom score
Percentage reduction in mean total symptom
score |
Day 1, Day 3 and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 syrup is a fixed dose combination
of Paracetamol 125 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine
Maleate 1 mg, Sodium citrate 60 mg and mentholated flavoured syrupy base q.s.
per 5 ml which is indicated for the symptomatic treatment of common cold. The
rationale behind this Active Post-Marketing Surveillance study is to document
the efficacy and safety of Sinarest Syrup for the treatment of common cold in
children. 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 upper respiratory tract. Allergic rhinitis is
nasal hypersensitivity symptoms persuaded by an immunologically mediated
(predominantly IgE dependent) inflammation as mucous membrane gets exposed to
allergens. The signs and symptoms of common cold overlap with allergic rhinitis
and show similar symptoms. 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 Syrup in
children of common cold.
|