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CTRI Number  CTRI/2024/02/063092 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   The Effects and safety of ZincorespTM Tablets/ Syrup in Patients Having Ear, Nose, Throat and Respiratory Disorders and Infections. 
Scientific Title of Study   A Prescription Event Monitoring (PEM) Study to Evaluate the Effects of Adjuvant Therapy with ZincorespTM Tablets/ Syrup in Patients Having Recurrent Ear, Nose, Throat and Respiratory Disorders and Infections. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
ZincoResp/PEM-3/2023, Version 2.0, dt. 15 July 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Thakare 
Designation  Principal investigator 
Affiliation  D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai 
Address  Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai
Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai
Raigarh
MAHARASHTRA
400706
India 
Phone  9869366927  
Fax    
Email  drvaishali015@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishali Thakare 
Designation  Principal investigator 
Affiliation  D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai 
Address  Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai
Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai

MAHARASHTRA
400706
India 
Phone  9869366927  
Fax    
Email  drvaishali015@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali Thakare 
Designation  Principal investigator 
Affiliation  D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai 
Address  Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai
Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai

MAHARASHTRA
400706
India 
Phone  9869366927  
Fax    
Email  drvaishali015@gmail.com  
 
Source of Monetary or Material Support  
apex laboratories private Limited, No.129 Estate main road, Industrial estate perungudi,Chennai-600096 tamil nadu, India 
 
Primary Sponsor  
Name  apex laboratories private Limited  
Address  No.129 Estate main road, Industrial estate perungudi, Channai-600096 tamil nadu, 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali Thakare  D.Y Patil University School of Medicine, Navi Mumbai.  Dept. of Pharmacology D Y Patil Medical College & Hospital Nerul Navi Mumbai
Mumbai
MAHARASHTRA 		 09869366927

drvaishali015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  ZincorespTM Syrup or ZincorespTM Tablet   ZincorespTM Syrup (5 ml syrup Once a day /twice a day). Or ZincorespTM Tablet (1 tablet Once a day /twice a day) for 8 weeks  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age above 2 years of any gender.
2. Patients having recurrent episodes of any of the following:
- Fever associated with respiratory tract infections (RTI)
- URTI (rhinitis (Acute/allergic/Nonallergic), Common cold, Sinusitis, pharyngitis, laryngitis, influenza)
- SARS-CoV-2
- Combined allergic rhinitis and asthma syndrome (CARAS)
- Acute otitis media,
- titis media with effusion,
- Chronic suppurative otitis media
3. Patients and parents who are willing to give consent for their or the child’s participation respectively in study. 
 
ExclusionCriteria 
Details  1. Any evidence of malignancy.
2. History and clinical findings suggestive of metabolic diseases
3. History and clinical findings suggest chronic respiratory tract diseases including interstitial lung disease (ILD) and cystic fibrosis.
4. History of respiratory tract surgery.
5. Known diagnosis of congenital cardiac defects. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in symptoms of ear, nose, throat, and respiratory disorders and/or infections   Baseline to Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Total number of patients with at least one episode of upper respiratory tract infections
(rhinitis, Common cold, Sinusitis, pharyngitis, laryngitis, otitis media, and influenza) 		 Baseline to Week 12 
Total number of patients with at least one episode of Acute otitis media, Otitis media with effusion, Chronic suppurative otitis media  Baseline to Week 12 
Total number of patients not having any episode of respiratory tract infections (URTI) or exacerbations of existing conditions during the study period.  Baseline to Week 12 
Total number of patients with Combined allergic rhinitis and asthma syndrome (CARAS).  Baseline to Week 12 
Total number of patients experiencing at least one episode of fever during the study period.  Baseline to Week 12 
Total number of patients requiring antimicrobial agents (antibiotics and antiviral drugs) during the study period.  Baseline to Week 12 
Total number of patients requiring hospital admission, but not requiring supplemental oxygen during the study period.  Baseline to Week 12 
Total number of patients requiring hospital admission, requiring supplemental oxygen during the study period.  Baseline to Week 12 
Number of days of hospitalization required during the study period.  Baseline to Week 12 
Total number of days of work lost by the patients due to illness during the study period.  Baseline to Week 12 
Total number of episodes of infections lasting more than 7 days during the study period.  Baseline to Week 12 
Time required to recover completely from infection during the study period.  Baseline to Week 12 
Investigator global assessment for efficacy  Week 12 
Investigator global assessment for safety and tolerability  Week 12 
Patient global assessment for efficacy  Week 12 
Patient global assessment for safety and tolerability  Week 12 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="97" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   29/02/2024 
Date of Study Completion (India) 17/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  
All eligible subjects who meet the inclusion and exclusion criteria will be part of the study.
A detailed history will be obtained from the patients included in the study.
After baseline assessment, patients will be followed-up during the study period (week 1 ± 3 days, and week 2 ± 3 days, week 3 ± 3 days week 4 ± 3 days, week 8 ± 3 days, week 12 ± 3 days]
 
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