| CTRI Number |
CTRI/2025/09/095260 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the role of Homeopathy in cases of chronic ear infection. |
|
Scientific Title of Study
|
Understanding the influence of miasm in cases of chronic otitis media using - COMOT-15 |
| 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 Shilpaben Pareshbhai Vaghela |
| Designation |
MD Scholar |
| Affiliation |
Anand Homeopathic Medical College and Research Institute, Anand. |
| Address |
Department of Homoeopathic medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road anand,388001
Department of Homoeopathic medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road anand,388001
Anand
GUJARAT
388001
India |
| Phone |
9574282237 |
| Fax |
|
| Email |
shilpavaghela34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupal Mehta |
| Designation |
M.D. (Organon of Medicine and Homeopathic Philosophy) |
| Affiliation |
Anand Homeopathic Medical College and Research Institute, Anand. |
| Address |
Department of Homoeopathic medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road anand,388001
Department of Homoeopathic medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road anand,388001
Anand
GUJARAT
388001
India |
| Phone |
7600020410 |
| Fax |
|
| Email |
dr.rupalmehta9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpaben Pareshbhai Vaghela |
| Designation |
M.D. scholar |
| Affiliation |
Anand Homeopathic Medical College and Research Institute, Anand. |
| Address |
Department of Homoeopathic medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road anand,388001
Department of Homoeopathic medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road anand,388001
Anand
GUJARAT
388001
India |
| Phone |
9574282237 |
| Fax |
|
| Email |
shilpavaghela34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Hospital Oops. Sardar baug, Anand 388001 |
|
|
Primary Sponsor
|
| Name |
Dr. Shilpaben Vaghela |
| Address |
20,11P Shreerang society, near narayan nagar, pamol road, Borsad, 388540 |
| 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 Shilpaben Vaghela |
Anand Homoeopathic Hospital, Anand |
Department of Homoeopathic medicine (room no. 1&4) and surgery (room no. 5), Opp. Sardar baug, nr. new bus stand, Anand, Gujrat, 388001
Anand
GUJARAT |
9574282237
shilpavaghela34@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H663||Other chronic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Each patient will receive individualized homoeopathic medicines selected on the basis of totality of symptoms and predominant miasmatic background (Psora, Sycosis, Syphilis, Tubercular). Potency, dose, and repetition will be decided as per the guidelines of Hahnemann’s Organon of Medicine and modified according to susceptibility and response. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above age of 14 years and all genders (including male, female and gender diverse individuals) are eligible for the study.
2.Patients with recurrent and chronic otitis media are eligible for the study.
3.Patients who are willing and are able to comply with the study protocol, including taking homoeopathic treatment, attending follow-up assessments are eligible for the study.
4.Patients who would give their written informed consent are eligible for the study. |
|
| ExclusionCriteria |
| Details |
1.Patients having otitis media requiring only surgical intervention will be excluded.
2.Patients below age of 14 years will be excluded.
3.Patients with significant cognitive impairments will be excluded.
4.Patients who are unable or unwilling to comply with the study protocol, such as adhering to treatment regimen and attending follow-up visits will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in COMOT-15 total score (ear symptoms, hearing function, mental health, and overall QoL) from baseline to end of treatment. |
Reduction in COMOT-15 total score (ear symptoms, hearing function, mental health, and overall QoL) from baseline to end of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/10/2025 |
| 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
|
This study focuses on understanding the influence of miasm in cases of chronic otitis media using COMOT-15 as an assessment tool. Chronic otitis media is a highly prevalent condition that often leads to hearing impairment, recurrent discharges, and reduced quality of life. Conventional treatment frequently results in recurrence and antibiotic resistance. Homoeopathy, with its holistic and individualized prescriptions, takes into account the miasmatic background (Psora, Sycosis, Syphilis, Tubercular) which influences disease susceptibility, progression, and recurrence. This study aims to evaluate how different miasms affect the clinical outcome of chronic otitis media and whether individualized miasmatic treatment can improve quality of life, as measured by the COMOT-15 scale. |