FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 


 
Close