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CTRI Number  CTRI/2026/01/102485 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective Observational 
Study Design  Other 
Public Title of Study   A record study to understand the scope of Homoeopathic medicines in the management of Acute Bronchiolitis in the paediatric age group 
Scientific Title of Study   ASSESING THE INITIATION CRITERIA AND OUTCOMES OF THE HOMOEOPATHIC INTERVENTION IN ACUTE BRONCHIOLITIS WITHIN INTEGRATED TREATMENT SETTING: A RETROSPECTIVE REVIEW. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Shravanee Atul Ghag 
Designation  Post Graduate Student 
Affiliation  Dr M L Dhawale Memorial Homoeopathic Institute and Hospital 
Address  304 Department of Paediatrics Dr M L Dhawale Memorial Homoeopathic Institute Palghar Palghar Boisar Road

Palghar
MAHARASHTRA
401404
India 
Phone  9920455081  
Fax    
Email  ghagshravanee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Mandal 
Designation  Associate professor  
Affiliation  Dr M L Dhawale Memorial Homoeopathic Institute and Hospital 
Address  304 Department of Paediatrics Dr M L Dhawale Memorial Homoeopathic Institute Palghar Palghar Boisar Road

Palghar
MAHARASHTRA
401404
India 
Phone  9833180915  
Fax    
Email  sonali.sonigoldfinch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonali Mandal 
Designation  Associate professor  
Affiliation  Dr M L Dhawale Memorial Homoeopathic Institute and Hospital 
Address  304 Department of Paediatrics Dr M L Dhawale Memorial Homoeopathic Institute Palghar Palghar Boisar Road

Palghar
MAHARASHTRA
401404
India 
Phone  9833180915  
Fax    
Email  sonali.sonigoldfinch@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr M L Dhawale Memorial Trust Hospital  
Address  Dr M L Dhawale Memorial Trust Hospital Palghar Boisar Road Palghar Dist Palghar Maharasthra 401404 
Type of Sponsor  Research institution and hospital 
 
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 Sonali Mandal  Dr. M L Dhawale memorial trust institute  Department of Paediatrics Dr M L Dhawale Memorial Homoeopathic Institute Palghar Palghar Boisar Road
Palghar
MAHARASHTRA 
9833180915

sonali.sonigoldfinch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MLDMHI, Palghar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  2.00 Year(s)
Gender  Both 
Details  1 Case Records of cildren diagnosed with Acute Bronchiolitis using ICD 10 Diagnostic criteria
2. Age group- 0 to 2 years of age.
3. Both genders- Boys and Girls.
4. Case Records of children diagnosed with Acute Bronchiolitis, along with other acute diseases involving sectors other than lower respiratory tract
5. Cases treated with Conventional treatment along with Homoeopathic Treatment in Integrated setting 
 
ExclusionCriteria 
Details  1. Case Records of children with congenital diseases, especially of the cardiorespiratory system and other life threatening conditions like malignancy and tuberculosis.
2. Case Records of children with severe Malnutrition.
3. Case records of children diagnosed with other acute lower respiratory tract illnesses- Bronchitis, Pneumonia. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify and study the initiation criteria and outcomes of the homoeopathic intervention in acute bronchiolitis within integrated treatment setting.  12 hourly follow up 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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)   09/02/2026 
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="6"
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   Acute bronchiolitis is a common lower respiratory infection in children under two years, with limited effectiveness of many conventional treatments leading to significant morbidity. Major clinical problems lies in its variable severity, lack of  definitive curative therapy, and wide differences in management practices across hospitals. Despite being largely viral in origin, children recieve unnecessary investigations, antibiotics, bronchodilators, steroids, increasing cost , side effects and caregiver anxiety. In developing countries additional changes include delayed presentation, malnutrition, overcrowding and limited access to standardized evidence based protocols. 

The research gap exist in the form of severity predictors, clinical patterns, risk factors for severity, treatment outcomes and predictors of prolonged hospital stay in acute bronchiolitis. Most guidelines are based on international data, which may not fully reflect local epidemiology, nutritional status, environmental exposure, healthcare facilities, also limited clarity on which clinical parameters best predict complications and poor outcomes in routine hospital settings. Hence Retrospective observational studies can bridge this gap by systematically analyzing existing pattern records to identify correlations and outcome predictors.

To fill this gap and achieve meaningful outcomes, Study will involve stepwise collection of demographic data, clinical features, investigations, treatment modalities and hospital record outcomes. The study reviews inpatient and outpatient records of children receiving both homoeopathic and conventional care to assess symptom progression, response to treatment, and need for supportive therapies such as oxygen. The aim is to generate qualitative and quantitative evidence on the role of homoeopathy, support better clinical decision-making, and guide future research in paediatric respiratory care.
 
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