| CTRI Number |
CTRI/2018/04/013235 [Registered on: 13/04/2018] Trial Registered Prospectively |
| Last Modified On: |
13/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of pus discharge from ear |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic treatment of chronic suppurative otitis media: double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1212-2819 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dilip Panakkada |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Homoeopathic Pharmacy, OPD room no. 10; Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9038603007 |
| Fax |
|
| Email |
drdilipan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rachna Goenka |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Homoeopathic Pharmacy, OPD room no. 10; Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9831250880 |
| Fax |
|
| Email |
cal.rachna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachna Goenka |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Homoeopathic Pharmacy, OPD room no. 10; Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9831250880 |
| Fax |
|
| Email |
cal.rachna@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt
Lake, Kolkata 700106, West Bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| 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 |
| Dilip Panakkada |
National Institute of Homoeopathy, Govt. of India |
OPD room no. 10,
Dept. of Homoeopathic
Pharmacy; Block GE,
Sector III, Salt Lake,
Kolkata 700106
Kolkata
WEST BENGAL |
9038603007
drdilipan@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 |
| Comparator Agent |
Identical placebo, indistinguishable from verum |
Identical placebo, indistinguishable from verum. Placebo each dose consists of 4-6 cane sugar globules no. 20 moistened with a single drop of 60Ëš OP ethanol, to be taken orally twice a day on clean tongue with empty stomach. Duration of therapy: 6 months |
| Intervention |
Indicated homoeopathic
medicines in centesimal
potencies |
Indicated homoeopathic
medicines in centesimal
potencies and in individualized dosage, as decided appropriate to the case or condition. In
centesimal scale, each dose will consist of 4-6 cane globules no. 20 moistened with the indicated medicine (preserved in 90% v/v
ethanol); to be taken orally on clean tongue with empty
stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of
therapy: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-70 years
2. Both sexes
3. Symptomatic for last 3 months
4. Diagnosed to be suffering from CSOM by the consultant ENT surgeon
5. Standard therapy for CSOM, if ongoing, discontinued for at least 1 month
6. Providing written informed consent
7. Literate patients; ability to read English or Bengali |
|
| ExclusionCriteria |
| Details |
1. CSOM with cholesteatoma
2. Patients who are too sick for consultation
3. Patients unable to read patient information sheets, and not giving consent to take part
4. Major ear surgery in last 6 months
5. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life
6. Pregnant women and lactating mothers
7. Substance abuse and/or dependence
8. Self-reported immune-compromised state, and
9. Undergoing any treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bengali version of the COMOT-15 questionnaire |
Baseline, after 3 months, and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/04/2018 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
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. Although there is no consensus on the duration of symptoms,
generally long lasting infection and irreversible mucosal damage over 3 months
is accepted as CSOM in clinical practice. The global burden
of illness from CSOM involves 65-330 million individuals with draining ears,
60% of whom suffer from significant hearing impairment. CSOM accounts for 28,000
deaths and a disease burden of over 2 million DALYs. We tested whether individualized homoeopathic (IH) medicines can produce any significantly different effect in comparison to placebo in
treatment of chronic suppurative otitis media (CSOM) in a double-blind, randomized, placebo controlled,
two parallel arms, clinical trial involving 142 patients (verum: 71; placebo: 71). The outcome measure is the Bengali version of the COMOT-15 questionnaire, to be assessed at baseline, after 3 months, and
after 6 months. Comparative analyses will be run to detect group differences if any. Results will be published in scientific journals |