| CTRI Number |
CTRI/2025/12/098945 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of Homoeopathic Constitutional Remedies for Acute Ear Infections in Children -A Randomized Controlled Trial |
|
Scientific Title of Study
|
To Find Out The Effectiveness Of Constitutional Homoeopathic Remedy In The Treatment Of Acute Suppurative Otitis Media At Pediatric Age 5-13 years A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Koijam Allena Devi |
| Designation |
PG SCHOLAR |
| Affiliation |
Room no 102 Pediatric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan |
| Address |
Room no 102 Pediatric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Room no 102 Pediatric Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
6009478967 |
| Fax |
|
| Email |
allenakoijam06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Koijam Allena Devi |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
6009478967 |
| Fax |
|
| Email |
allenakoijam06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Koijam Allena Devi |
| Designation |
PG SCHOLAR |
| Affiliation |
Room no 102 Pediatric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan |
| Address |
Room no 102 Pediatric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Room no 102 Pedaitric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
6009478967 |
| Fax |
|
| Email |
allenakoijam06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road
Near RIICO Bus Stand Hanumamgarh Road Sri Ganganagar Rajasthan 335002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Koijam Allena Devi |
Tantia University |
Room no-102 Paediatric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN |
06009478967
allenakoijam06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ganganagar Homoeopathic Medical College Hospital and Research Institite |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H660||Acute suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
The dose and repetition of medicines including mother tinctures may vary according to the susceptibility and sensitive to the patient the acute nature of the disease and the age and vitality of the individual .In this trial dosage repetition and dispensing (in the form of gobules no 40)of indidualised homoeopathic medicine will be as per the need of the case and the guidelines of the organon of medicine .The selected dose of mother tincture (approx.20 to 60 drops)represent a minimum safe and standardized range the dose of the repetition will be determined according to the need of the case and previous research evidences.Reassessment will be done at the end of 3 months with all interventions closely monitored for safety throughout the study |
| Comparator Agent |
placebo |
Placebo will be admisnistrated in homoeopathic globules |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Children in both sexes
Age 5-13 years
Patients parents willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Inability to follow study protocol
Patient with advance pathological condition along with Acute Suppurative Otitis Media will be excluded
Chronic Suppurative Otitis Media -history of ear discharge lasting ,ore then 6 weeks
Complication of ASOM including
Matoiditid
Facial nerve palsy
Intracranial infection
History of ear surgery or any congenital ear malformations |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Participant Receiving Constitutional Homoeopathic Medicine are excepted to show a greater reduction in the treatment of Acute Suppurative Otitis Media |
6 months until final examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
22/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/12/2025 |
| 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 Yet Recruiting |
| 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
|
Aim- To find out the effectiveness of Homoeopathic Medicine in case of Acute Suppurative Otitis Media Objectives- To analyze the different trigger factor relevant to Acute Suppurative Otitis Media To explore a group of most effective Homoeopathic medicine in the treatment of Acute Suppurative Otitis Media INTRODUCTION- Acute Suppurative otitis media is common cause of morbidity in children .It defined as inflammation of mucoperiosteal lining of the middle ear .If the duration of illness is more than two weeks it is termed as an Chronic Suppurative otitis media .Children are more prone for acute Suppurative otitis media because the Eustachian tube more communicating throat with ears are straight and short. Acute Suppurative otitis media may be one of the complication of other respiratory infections. It is nearby always a sequel to an upper respiratory tract infection which is seen commonly during childhood. ASOM in children is commonly caused by Streptococcus pneumoniae Haemophilis influenza and Moraxella catarrhalis .Very rarely it may be caused by due to Staphylococcus and gram negative organism. In later is more common in immunocompromised hosts. STUDY PROCEDURE-
The present study will be conducted with a target sample size of 100 participants. Each patient will undergo detailed case taking including a comprehensive history and general physical examination to confirm the diagnosis of Acute Suppurative Otitis Media as per ICD-11 criteria. Only those patients meeting the eligibility requirements will be included in the study. Following inclusion all 100 participants will be randomized into two equal groups of 50 each using the dice method where odd numbers will be assigned to the treatment group and even numbers to the control group. The severity of ASOM will be assessed using the AOM-SOS (Acute Otitis Media–Severity of Symptoms) Scale before the initiation of treatment. Participants in the treatment group will receive individualized homeopathic medicines while the control group will receive a placebo. Each patient will have a minimum of four follow-ups at intervals of seven days over a period of one month with adjustments based on clinical condition. The AOM-SOS score will be recorded at each follow-up to monitor clinical improvement and evaluate treatment efficacy in both groups. After completion of the follow-up period appropriate statistical tools will be applied to analyze the collected data. The results will be interpreted by comparing the changes in AOM-SOS scores between the individualized homeopathic treatment group and the placebo group followed by a detailed discussion and conclusion based on the findings. |