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CTRI Number  CTRI/2024/02/063382 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Management of Chronic Suppurative Otitis Media with Homoeopathy. 
Scientific Title of Study   Efficacy of Individualized Homoeopathy in Management of Chronic Suppurative Otitis Media: A Single-blind, Randomized, Plcebo-Controlled 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 Punam Kumari 
Designation  Research Officer(H.) 
Affiliation  Dr D P Rastogi Central Research Institute of Homoeopathy 
Address  Dr D P Rastogi Central Research Institute of Homoeopathy, A-1/1, Sector-24, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9910450787  
Fax    
Email  drpunamk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Punam Kumari 
Designation  Research Officer(H.) 
Affiliation  Dr D P Rastogi Central Research Institute of Homoeopathy 
Address  Dr D P Rastogi Central Research Institute of Homoeopathy, A-1/1, Sector-24, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9910450787  
Fax    
Email  drpunamk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Punam Kumari 
Designation  Research Officer(H.) 
Affiliation  Dr D P Rastogi Central Research Institute of Homoeopathy 
Address  Dr D P Rastogi Central Research Institute of Homoeopathy, A-1/1, Sector-24, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9910450787  
Fax    
Email  drpunamk@gmail.com  
 
Source of Monetary or Material Support  
D P Rastogi central research institute of homeopathy A-1/1, sector 24, Noida, Uttar Oradesh 
 
Primary Sponsor  
Name  Central council for research in Homoeopathy 
Address  Block D Institutional area Janakpuri New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Punam Kumari room number two hundred twenty five first floor  Dr D P Rastogi central research institute of homeopathy  Sector 24 Noida Room number 225 first floor
Gautam Buddha Nagar
UTTAR PRADESH 		 9910450787

drpunamk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (2) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicines  Individualized Homoeopathic medicines should be prescribed on basis of totality 4 globules of 30 sizes BD or TDS should be given orally as per the susceptibility of the patient according to Organon of homoeopathy 
Comparator Agent  Placebo  Placebo 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Diagnosed cases of tubotympanic type chronic suppurative otitis media of more than 2weeks

Age group from 1 to 45 years

Both sexes
Subjects who have given the written informed consent 
 
ExclusionCriteria 
Details  chronic suppurative otitis media of atticoantral type
Patient with history of noise exposure
Patient with history of ear surgery
Patient not willing to be part of the study
Patients with uncontrolled chronic illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• To evaluate the VAS for ear discharge, pain, and deafness
To evaluate changes by clinical and otoscopy examination.
To assess the hearing level using audiometry test
To evaluate the quality of life using chronic otitis media outcome
test-15(COMOT -15) questionnaire
To assess the recurrence of CSOM during treatment
 		 • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month.
• Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month.
•COMOT-15 Questionnaires will be assess at baseline and every month. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare and assess the clinical improvement using otoscopy and physical examination from
baseline, 3rd, 6th, 9th and 12th month
ï‚· To assess hearing impairment using audiometry(pure tone) test at baseline, 3rd, 6th, 9th and 12 th month
ï‚· To assess and compare the change in quality of life of CSOM using COMOT-15 questionnaire
scores at baseline and every month.
ï‚· To assess the recurrence of CSOM during treatment 		 1. Otoscopy and audiometry (PTA) test -Baseline, 3rd, 6th, 9th and 12th month
2.COMOT-15 questionnaire-Baseline and every month 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   06/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response (Others) - 
  3. Who will be able to view these files?
    Response (Others) - 

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 06-03-2024 and end date provided 02-01-2027?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Title : Efficacy of Individualized Homoeopathy in management of Chronic suppurative otitis media: A single blind, Randomized, Placebo controlled trial
Study Duration: 2year 6months
Study Site: DDPRCRI(H.), Noida
Objectives:
1. Primary: To evaluate the efficacy of Individualized homoeopathic medicine in the management of chronic suppurative otitis media using VAS for ear discharge, pain and deafness
2. Secondary: To evaluate efficacy of individualized homoeopathy in CSOM by comparing Clinical and Otoscopy examination.
To assess hearing level using audiometry(Pure tone) test.
To evaluate quality of life using COMOT-15 Questionnaires.
To assess recurrence of CSOM during treatment
Sample size: 140
Inclusion criteria: Diagnosed case of tubotympanic type of CSOM of duration >2 weeks
Age- 1-45 yr
Both sexes
Subject who have given written  informed consent
 Exclusion criteria:
CSOP of atticoantral type(unsafe)
Subject with H/O noise exposure
Subject with H/O ear surgery
Subject with uncontrolled chronic illness.
Subject not willing to part of the study

 
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