| 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
|
|
|
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
|
|
|
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
|
|
|
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. |