| CTRI Number |
CTRI/2025/07/090821 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of zinc as an adjuvant therapy in the treatment of severe pneumonia in hospitalised children between 2 months to 5 years of age: A randomised control trial
|
|
Scientific Title of Study
|
Efficacy of zinc as an adjuvant therapy in the treatment of severe pneumonia in hospitalised children between 2 months to 5 years of age:randomised controlled trial
|
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUDUKANAGOUDA |
| Designation |
POSTGRADUATE |
| Affiliation |
Karnataka medical college and research institute |
| Address |
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE,HUBLI
Vivek hostel Karnataka institute of medical sciences and research institute,hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9108736810 |
| Fax |
|
| Email |
mudukanagouda.karekal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAKASH K WARI |
| Designation |
Professor |
| Affiliation |
Karnataka medical College and research institute hubli |
| Address |
Department of pediatrics,Karnataka medical College and research institute hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9448063128 |
| Fax |
|
| Email |
pkwari55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRAKASH K WARI |
| Designation |
Professor |
| Affiliation |
Karnataka medical College and research institute hubli |
| Address |
Department of pediatrics,Karnataka medical College and research institute hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9448063128 |
| Fax |
|
| Email |
pkwari55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics Karnataka medical college and research institute hubli |
|
|
Primary Sponsor
|
| Name |
Mudukanagouda |
| Address |
Post graduate Karnataka medical college and research institute hubli |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Mudukanagouda |
Karnataka medical College and research institute hubli |
hubli
Dharwad
KARNATAKA |
9108736810
mudukanagouda.karekal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka institute of medical sciences hubli ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
syp zinc |
Less than 6 Months 10mg/day
More than 6 Months 20 mg/day
Orally once a day for 7 days |
| Comparator Agent |
Without SYP zinc |
Less than 6 Months 10mg/day
More than 6 Months 20 mg/day
Orally once a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
As per WHO guidelines: Child with severe pneumonia with clinical features of lower chest indrawing, Unable breastfeed, lethargy, convulsions, unconsciousness, severe respiratory distress, central cyanosis |
|
| ExclusionCriteria |
| Details |
Children with any congenital heart disease, congenital lung disease, Children with aspiration pneumonia, Children with history of wheezing and recurrent chest infection, Children already taking zinc 2 weeks prior to study Children who need mechanical ventilation are excluded from this study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of tachypnea in hours at the time of discharge |
Improvement of tachypnea in hours at the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in chest indrawing in hours,Improvement in oxygen saturation in hours,Baseline serum zinc level Duration of Hospitalisation (h) |
Improvement in chest indrawing in hours,Improvement in oxygen saturation in hours,Baseline serum zinc level Duration of Hospitalisation (h) |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After taking consent, patient demographic details, including name, age, sex, and address, will be delicately obtained from parents to uphold full privacy. The patient will undergo standard pneumonia treatment as per Karnataka institute of medical sciences, Hubli standard operation protocol (SOP). Blood sample collected for serum zinc level at the time of admission. Subsequently, children will be randomly assigned to Groups A and B by computer randomisation. Group A will receive syrup zinc (10 mg/day in children under 6 months of age and 20 mg/day in children above 6 months of age during hospitalisation for 7 days) along with antibiotics. In contrast, Group B will solely receive antibiotics without zinc supplementation. Respiratory rate, tachypnea definition based on age (respiratory rate >50 breaths/min in children <12 months of age, or >40 breaths/min in children >12 months of age), nasal flaring, and chest indrawing and oxygen saturation (SpO2) will be observed every 8 hourly, with SpO2 below 90% classified as hypoxemia. For patients on oxygen therapy, after 2-minute cessation we will assess respiratory rate, chest indrawing, and oxygen saturation. Clinical deterioration will be assessed by respiratory rate and signs of severe pneumonia. Continuous monitoring will occur and documentation done every 8th hourly extending until resolution of symptoms of pneumonia. All data will be meticulously recorded in a predefined proforma, strictly following exclusion criteria to control confounders and bias in study results. |