| CTRI Number |
CTRI/2025/02/080086 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of CSOM |
|
Scientific Title of Study
|
To evaluate the effectiveness of Calcarea Group in the management of Chronic Suppurative Otitis Media: An Open Label Prospective Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tulika |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital,1- Viraj Khand, Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8009233733 |
| Fax |
|
| Email |
jaiswaltulika98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anirudh Kumar |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital,1- Viraj Khand, Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8953883449 |
| Fax |
|
| Email |
Kumardranirudh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anirudh Kumar |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital,1- Viraj Khand, Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8953883449 |
| Fax |
|
| Email |
Kumardranirudh@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomtinagar Lucknow-226010, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Tulika |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomtinagar Lucknow |
| Type of Sponsor |
Other [[Self]] |
|
|
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 |
| Dr Tulika |
State National Homoeopathic Medical College and Hospital |
OPD-7, Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1- Viraj Khand Gomtinagar, Lucknow-226010
Lucknow
UTTAR PRADESH |
8009233733
jaiswaltulika98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee State National Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H652||Chronic serous otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualize Calcarea Group Homoeopathic Medicine |
Intervention- The Calcarea group
will be selected according to the totality of symptoms.
Dosage- Medicine will be given in varying potencies of
decimal/ centesimal/ millesimal scales as identified from
detailed case taking.Each dose shall consist of cane
sugar medicated with single medicine. Route-Medicine
will be administered via oral route. Dosage and
repetition will depend upon the individual requirement of
the cases as per the guidelines from organon of
medicine. The patient will be called for follow up after
every 15 days and final assessment will be done after 6
months. At every follow up after reexamining the case it
will be decided whether the patient will receive a dose of
individualized homoeopathic medicine or placebo. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients both male and female will be included in the study.
2.Cases of patients between 2-50 yrs of age.
3.Patients with clinical symptomatology like otalgia and otorrhea with or without hearing disturbances.
4.Cases with duration of discharge more than six weeks used to make the diagnosis.
5.Patients who are willing to fill consent form.
6.Patient taking no other treatment for CSOM.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to give their consent for study and not complying regular follow up.
2.Cases with advanced pathology like Cholesteatoma, epidural abscess, meningitis or which requires major surgical interventions.
3.Pregnant and lactating women.
4.Patients with unstable psychiatric illness or other life-threatening systemic disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the COMOT-15 score at the baseline and after 6 months of treatment to know the effectiveness of Calcarea group. |
12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The aims to assess the effectiveness of the primary medicine from the Calcarea group in cases of Chronic Suppurative Otitis Media (CSOM) and will assist in the clinical validation of the symptoms associated with the prescribed Calcarea group medicine. |
12 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
CSOM is a chronic ear infection marked by ear discharge and a permanent perforation of the tympanic membrane. CSOM can result in hearing loss, middle ear inflammation, and ossicular damage. The chronic nature of CSOM, with poor responses to conventional treatments like antibiotics, highlights the need for alternative therapies like homeopathy. CSOM affects millions, causing preventable hearing loss. In countries like India, the prevalence is high, especially in rural areas. Modern treatments are often ineffective, prompting the search for alternative options. Homeopathy, which focuses on individualized treatments, may offer a potential solution. This study aims to evaluate the effectiveness of homeopathic remedies from the Calcarea group in managing Chronic Suppurative Otitis Media (CSOM), a long-lasting ear infection that causes ear discharge, hearing loss, and tympanic membrane perforation. Current treatments are often ineffective, particularly in the long term, highlighting the need for alternative therapies like homeopathy. The study will involve 30 patients with CSOM, aged 2-50 years, who will receive homeopathic treatment based on detailed case-taking. Their progress will be monitored using the Chronic Otitis Media Outcome Test-15 (COMOT-15), which assesses their quality of life. Patients will be followed up for six months, with regular assessments and data analysis to determine the treatment’s effectiveness. The study aims to demonstrate that remedies from the Calcarea group can significantly improve symptoms of CSOM, such as ear discharge and hearing loss, and contribute to homeopathic practice in treating this condition. This study aims to assess the effectiveness of the primary medicine from the Calcarea group in cases of Chronic Suppurative Otitis Media (CSOM) and will assist in the clinical validation of the symptoms associated with the prescribed Calcarea group medicine. |