| 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
|
|
|
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
|
|
|
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. |