| CTRI Number |
CTRI/2024/02/063048 [Registered on: 22/02/2024] 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
|
To Effects of ZincorespTM Syrup in Children Aged 2- 12 Years Having Respiratory Disorders and Infections. |
|
Scientific Title of Study
|
A Prescription Event Monitoring (PEM) Study to Evaluate the Effects of Adjuvant Therapy with ZincorespTM Syrup in Children Aged 2- 12 Years Having Recurrent Respiratory Disorders and Infections. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZincoResp/PEM-1/2023, 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
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
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
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
|
|
|
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. |
D Y Patil University
School of Medicine,
Department of Sports
Sciences, Room No. 2,
2nd Floor, Sector 5,
Nerul, Navi Mumbai,
Maharashtra, India.
Mumbai MAHARASHTRA
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
|
|
|
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 |
ZincorespTM Syrup (5 ml) syrup twice a day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 2-12 years of age of any gender.
2. Children having recurrent episodes of any of the following:
- Fever associated with respiratory tract infections (RTI)
- URTI (rhinitis, pharyngitis, laryngitis, otitis media, influenza)
- LRTI (pneumonia, bronchitis, and bronchiolitis)
- Bronchial asthma
- COPD
- SARS-CoV-2
- Combined allergic rhinitis and asthma syndrome (CARAS)
- Pulmonary tuberculosis
3.Parents are willing to give consent for the child’s participation 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 respiratory disorders and/or infections |
Baseline to Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total number of children with at least one episode of upper respiratory tract infections
(rhinitis, pharyngitis, laryngitis, otitis media, and influenza) |
Baseline to Week 12 |
Total number of children with at least one episode of lower respiratory tract infections
(pneumonia, bronchitis, and bronchiolitis) |
Baseline to Week 12 |
| Total number of children not having any episode of respiratory tract infections (URTI or LRTI) or exacerbations of existing conditions |
Baseline to Week 12 |
Total number of children with Bronchial asthma, Combined allergic rhinitis and asthma.
syndrome (CARAS). |
Baseline to Week 12 |
| Total number of children experiencing at least one episode of fever during the study period. |
Baseline to Week 12 |
Total number of children requiring antimicrobial agents (antibiotics and antiviral drugs) during the study period.
|
Baseline to Week 12 |
Total number of children requiring hospital admission, but not requiring supplemental
oxygen during the study period. |
Baseline to Week 12 |
Total number of children 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 parents due to the child’s 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 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="87" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/02/2024 |
| Date of Study Completion (India) |
26/04/2024 |
| 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 parents of children included in the study. After baseline assessment, a children 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] |