| CTRI Number |
CTRI/2024/11/077243 [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 New Tablet for Adult with Common Cold: Safety and Efficacy Study |
|
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 New Tablet in adults with common cold. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 086-20 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, 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 Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola, Santacruz (E), 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 Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, Maharashtra India
Mumbai (Suburban) MAHARASHTRA 400055 India |
| Phone |
8451868061 |
| 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, near Hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, India. Mumbai
(Suburban) MAHARASHTRA 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 Siddharth Gautam |
Madhuraj Maternity and Nusring Home |
Madhuraj Maternity and Nusring Home
Pandeypur Trimuhani, Police Line Road
Varansi, Uttarpradesh-221002 Varanasi UTTAR PRADESH |
7509950886
siddgolu@gmail.com |
| Dr Harsh Vardhan Singh |
My PHC ENT Clinic |
My PHC ENT Clinic, Shop No.1, First Floor, Gopi Tower, Saguna More, Patna-810503 Patna BIHAR |
9835204471
singhharshvardhan30@gmail.com |
| Dr Vidya B Thimmaiah |
Navya Multispecialty Hospital |
#363/319, beside RR gold palace, Bangalore Bellary road, old town yelhanka, Bangalore 560064 Bangalore KARNATAKA |
9535864663
vidyabthimmaiah@gmail.com |
| Dr Neerja Pethe |
Shree E.N.T Nursing Home |
Shree E.N.T Nursing Home, B/102-1, Ketayun Mansion Society, Hahaji Raje Marg, above Thakkar Bakers, Vileparle (East), Mumbai- 400057 Mumbai MAHARASHTRA |
7798094671
neerupethe@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 New Tablet- FDC of
Paracetamol 500 mg,
Phenylephrine Hydrochloride 10
mg and Chlorpheniramine
Maleate 2 mg per tablet |
Sinarest New Tablet: 1 tablet
thrice a day for the active PMS
duration of 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the ages of 18 to 65 years.
Patients of either sex including male or female.
Patients with a confirmed diagnosis of common cold.
Patients who can adhere to the protocol and are ready to sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Patients hypersensitive to the investigational product
Patients with severe hepatic or renal dysfunction
Pregnant or lactating Women
Patients who cannot adhere to the Protocol (mentally ill or patients with psychological problems)
|
|
|
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 |
| 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 New Tablet is a fixed dose
combination of Paracetamol 500 mg, Phenylephrine 10mg and Chlorpheniramine
Maleate 2mg which is indicated for the symptomatic treatment of common cold .
Common cold is the most frequently encountered disease in medical practice. It
is the most frequent human illness and is caused by members of several families
of viruses. The most likely offenders are the ±100 serotypes of rhinoviruses.
Common cold affects the upper airways, sometimes in association with low-grade
fever and systemic symptoms, and usually presents with symptoms including
cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea,
sneezing,headaches, myalgia and fever. Symptoms usually peak at 2 to 3 days and
have a mean duration of 7 to 10 days. As per the American Academy of Family
Physicians, there are no effective antivirals to cure the common cold but there
are few effective measures to prevent it including vaccines so ideally the
treatment should focus on symptomatic relief rather than treatment for the same.
According to the guidelines of DPHHS and Cochrane Review the combination of
analgesics, decongestants and antihistamines can provide symptomatic relief
from the multiple symptoms of common cold. Paracetamol belongs to a class of
Nonsteroidal Anti-inflammatory Drugs (NSAID) and exhibits good central
analgesic and antipyretic action. Chlorpheniramine maleate is a
first-generation antihistaminic agent and competitively binds to H1 receptors
in the nasal mucosa to prevent the histamine-induced vasoreactive responses
exhibiting anti-inflammatory as well as anti-allergic actions. The
anti-cholinergic action of Chlorpheniramine Maleate is responsible for the
decrease in nasal discharge. Phenylephrine is a selective adrenergic receptor
agonist, which is an effective nasal decongestant. Its dominant and direct
vasoconstricting effects on capacitance blood vessels of the nasal mucosa
decrease blood vessel diameter and lead to nasal decongestion. Combinations
with the same proposed ratio of Sinarest New Tablet are available as OTC in
developed as well as highly regulated countries like Australia, New Zealand,
the US, etc and used by patients for symptomatic relief of common cold. Taking
into account, the superiority in efficacy and safety of this fixed-dose
combination, we are proposing this Active Post-Marketing Surveillance (PMS) of
Sinarest New tablet in India. The rationale behind this Active PMS is to
document the efficacy and safety of Sinarest New Tablet for the treatment of
common cold in Indian patients.
|