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CTRI Number  CTRI/2017/03/008081 [Registered on: 14/03/2017] Trial Registered Prospectively
Last Modified On: 03/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homeopathic treatment of ear discharge 
Scientific Title of Study   An open observational trial of individualized homeopathic treatment in chronic suppurative otitis media and psychometric analysis of Chronic Otitis Media Outcome Test 15 (COMOT-15) Bengali questionnaire 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1193-8350  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subhranil Saha 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  OPD No. 11, Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9836187425  
Fax    
Email  drsubhranilsaha@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subhranil Saha 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  OPD No. 11, Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9836187425  
Fax    
Email  drsubhranilsaha@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Subhranil Saha 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  OPD No. 11, Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9836187425  
Fax    
Email  drsubhranilsaha@hotmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of west Bengal; Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India 
 
Primary Sponsor  
Name  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Govt of west Bengal 
Address  Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India 
Type of Sponsor  Government medical college 
 
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 
Rachna Goenka  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal  ENT OPD, every Thursday, Drainage Canal Road, Doomurjala
Haora
WEST BENGAL 
9831250880

cal.rachna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Suppurative Otitis Media (CSOM),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homeopathic medicine in centesimal or 50 millesimal potencies, as appropriate  In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean tongue in empty stomach. Duration of therapy: 6 months 
Comparator Agent  None  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age 18 to 65 years
2. Both sexes
3. Symptomatic for last 3 months, and
4. Standard therapy for CSOM, if ongoing, discontinued for at least 1 month 
 
ExclusionCriteria 
Details  1. Patients who are too sick for consultation
2. Unwilling to stay after the doctor’s visit
3. Uunable to read patient information sheets
4. Not giving consent to take part
5. Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life
6. Major ENT surgery in last 6 months
7. Currently receiving homeopathic treatment for chronic condition(s)
8. Pregnant and lactating women
9. Self-reported immune-compromised state
10. Substance abuse and/or dependence 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Chronic Otitis Media Outcome Test (COMOT-15) questionnaire (translated Bengali version)  At baseline, after 3 months, and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
CSOM severity measuring 0-10 numeric rating scale (NRS)  At baseline, after 3 months, and after 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2 
Date of First Enrollment (India)   06/04/2017 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic suppurative otitis media (CSOM) is the result of an initial episode of acute otitis media (AOM), followed by chronic infection of middle ear and mastoid mucosa and is characterized by a persistent discharge from the middle ear through a tympanic perforation. It is an important cause of preventable hearing loss, particularly in the developing world. The global burden of illness from CSOM involves 65-330 million individuals with draining ears, 60% of whom suffer from significant hearing impairment. The majority of the homeopathy research studies revealed promising role of homeopathic treatment in otitis media. However, the focus was principally on acute otitis media; and CSOM remained under-researched. This study presents the first prospectively collected data using the Bengali COMOT-15 and effectiveness of individualized homeopathy treatment in CSOM. In this project, we intend to develop translated Bengali version of COMOT-15 through standardized forward-backward translation method, to validate it and test its psychometrics on 100 CSOM patients in the ENT outpatient of Mahesh Bhattacharyya Homoeopathic Medical College & Hospital. Following that, we intend to use it as an outcome measure in an open observation trial testing usefulness of individualized homeopathic treatment in CSOM. The study will start in April 2017 and is estimated to continue up to 2 years. All the patients will be treated with individualized homoeopathic medicines in both centesimal and 50 millesimal potencies as per need of the case. Data will be collected at baseline, after 3 months, and after 6 months. The generated results will be analyzed in the end using appropriate statistical tests and the results will be published in scientific research journals.

 
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