| CTRI Number |
CTRI/2025/05/087985 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of homeopathic medicine in improving respiratory infections in infants and children |
|
Scientific Title of Study
|
Efficacy of Homeopathy Intervention in Managing Upper Respiratory Infections in Infants and Children - A Double-blind RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemant Bhargav |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) Bengaluru |
| Address |
Room No 2, IMD Block, Yoga Division, Hosur Main Road, NIMHANS, Bengaluru
Room No 2, IMD Block, Yoga Division, Hosur Main Road, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995730 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemant Bhargav |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) Bengaluru |
| Address |
Room No 2, IMD Block, Yoga Division, Hosur Main Road, NIMHANS, Bengaluru
Room No 2, IMD Block, Yoga Division, Hosur Main Road, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995730 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shioshankar Bondre |
| Designation |
Medical officer |
| Affiliation |
ANTARBHARTI HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No 1, Antarbharti OPD Block, Dabha Nagpur, Antarbharti Homeopathic Medical College, Nagpur
Room No 1, Antarbharti OPD Block, Dabha Nagpur, Antarbharti Homeopathic Medical College, Nagpur
Nagpur
MAHARASHTRA
440023
India |
| Phone |
08762019348 |
| Fax |
|
| Email |
urs.aatmiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIMHANS, Room 1, IMD Block, Integrative Medicine Department, Bengaluru, Karanataka 560029 India |
|
|
Primary Sponsor
|
| Name |
NIMHANS Hospital |
| Address |
Room No1, IMD Block, Integratiev Medicine Department, Hosur Main Road, Bengaluru 560029 Karnataka India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shioshankar Bondre |
ANTARBHARATI HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Room No 1, OPD Block, Department of Homeopathic Medicine, Antarbharati Homeopathic Medical college and Hospital, Dabha, Nagpur
Nagpur
MAHARASHTRA |
8762019348
urs.aatmiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ANTARBHARTI HOMOEOPATHIC MEDICAL COLLEGE and HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Management |
Use of anti-histaminics and antibiotics as recommended by a conventional pediatrician; Dose standard as per age per kg body weight dose, frequency: 3 times a day; route of administration oral & total duration of intervention: 14 days and sos after that till next 6 months |
| Intervention |
Homeopathy treatment |
Based on presenting symptoms: common homeopathic medications such as Belladonna, Bryonia, Gelsemium, Arsenic Album, Nux Vomica, Rhus Tox and Natrum Mur based on presenting symptoms.
Dose 30c, frequency: 3 times a day; route of administration oral & total duration of intervention: 14 days and sos after that till next 6 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Patients older than one day, presenting themselves with at least one of five chief complaints (runny nose, sore throat, fever, ear pain, sinus pain or cough), and onset of symptoms not more than 7 days before, were eligible to participate. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria were among others severe mental impairment, severe chronic diseases such as severe cardiac or respiratory disorders, malignancy, spinal cord injuries or drug abuse. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Response rate: percentage of patients with complete recovery or major improvement after 14 days |
day 0, day 7, day 14, day 28 and follow-up at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to onset of first improvement, patient satisfaction, sleep quality, adverse events, number of hospital consultations required in next 6 months. |
day 0, day 7, day 14, day 28 and follow-up at 6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory infections/complaints in a primary care setting in infants and children. We aim to recruit 300 children, 150 in each arm, and follow a randomized controlled double blind active controlled design, with one arm receiving homeopathy treatment and other arm receiving conventional treatment. The primary outcome variable is response rate and recovery at 14 days. We also aim at assessing time to onset of first improvement, sleep quality, adverse events, patient satisfaction and number of hospital consultations and hospitalization on follow-up at 6 months. |