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CTRI Number  CTRI/2025/12/099257 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathy in preventing Influenza like Illness 
Scientific Title of Study   Efficacy of Homoeopathic intervention Influenzinum 30 in preventing Influenza-like Illness (ILI) at urban slums of Delhi - cluster-randomized, double-blind, placebo-control trial. 
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 Debadatta Nayak  
Designation  Assistant Director (H)/ Scientist IV  
Affiliation  Central Council for Research in Homoeopathy  
Address  Epidemic cell, Room No. 303, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri

South West
DELHI
110058
India 
Phone  9873040412  
Fax    
Email  drdnayak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debadatta Nayak  
Designation  Assistant Director (H)/ Scientist IV  
Affiliation  Central Council for Research in Homoeopathy  
Address  Epidemic cell, Room No. 303, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri


DELHI
110058
India 
Phone  9873040412  
Fax    
Email  drdnayak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Debadatta Nayak  
Designation  Assistant Director (H)/ Scientist IV  
Affiliation  Central Council for Research in Homoeopathy  
Address  Epidemic cell, Room No. 303, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri


DELHI
110058
India 
Phone  9873040412  
Fax    
Email  drdnayak@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri, New Delhi 110058, India 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65, Institutional area, opp. D block, Janakpuri, New Delhi - 110058  
Type of Sponsor  Government funding agency 
 
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 Debadatta nayak  Central Council for Research in Homoeopathy  Department of Epidemic cell, Room 303, 61-65, institutional area, opp. D block, Janakpuri
South West
DELHI 		 9873040412

drdnayak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Influenza like Illness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Influenzinum 30  02 pills in each dose of the Influenzinum 30, to be given per week from January to March for children. 04 pills in each dose of the Influenzinum 30, to be given per week from January to March fr adults. 
Comparator Agent  Placebo  02 pills in each dose of the Placebo, to be given per week from January to March for children. 04 pills in each dose of the Placebo, to be given per week from January to March for adults. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Voluntary written informed consent by the family head. 
 
ExclusionCriteria 
Details  Pregnant women and lactating mother
Infants below age of 1 year
Individuals taking other preventive medicines for ILI.
Patients with malignancy, immunocompromised state, life threatening diseases, end stage diseases.
Symptoms of acute febrile illness/ influenza like illness at the time of enrolment.
Patient with symptoms of acute infectious illnesses at the time of enrolment.
Not willing to give written informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Influenza-like Illness between the groups  Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week, 9 week, 10 week, 11 week, 12 week, 13 week, 14 week, 15 week, 16 week 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of AUFI between the groups   Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week, 9 week, 10 week, 11 week, 12 week, 13 week, 14 week, 15 week, 16 week 
Changes in severity of symptoms between the groups during post prophylactic/ climatic infections   12 Weeks 
Mean duration of acute febrile illnesses between the cohorts   16 week 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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   Phase 3 
Date of First Enrollment (India)   25/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Influenza like Illness has risen exponentially over the last two decades and has accorded a huge burden on economy and health infrastructure of countries especially those that are developing. Due to its high population density, India has shown vulnerability for rapidly evolving micro-organisms such as Influenza. This cluster-randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy of Influenzinum 30 in preventing influenza among residents of 20 urban slum clusters in Delhi. Participants will receive weekly doses of the intervention or placebo from January to March for two years, along with IEC materials. Primary outcome is incidence of Influenza. Secondary outcomes include incidence and severity of acute undifferentiated febrile illness and mean duration of illness. The study will generate robust clinical evidence on the preventive role of homeopathy against Influenza and other febrile illnesses.

 

 
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