| CTRI Number |
CTRI/2025/09/094436 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicine in the management of Adenoid Hypertrophy in Children |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicine in management of Adenoid Hypertrophy in Children- A Prospective Single Arm 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 |
Dr Mansi Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
Nehru Homoeopathic Medical College and Hospital B Block Defence Colony New Delhi, 110024 South DELHI 110024 India |
| Phone |
7827755607 |
| Fax |
|
| Email |
mansiaggarwal208@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bipin Jethani |
| Designation |
HOD, Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
Nehru Homoeopathic Medical College and Hospital B Block Defence Colony New Delhi, 110024 South DELHI 110024 India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mansi Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
Nehru Homoeopathic Medical College and Hospital B Block Defence Colony New Delhi, 110024 South DELHI 110024 India |
| Phone |
7827755607 |
| Fax |
|
| Email |
mansiaggarwal208@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department of Nehru Homoeopathic Medical College and Hospital
B Block Defence Colony Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital
B Block Defence Colony New Delhi 110024 |
| 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 |
| Dr Mansi Aggarwal |
Nehru Homoeopathic Medical College and Hospital |
Department of Organon of Medicine and Homoeopathic Philosophy
Nehru Homoeopathic Medical College and Hospital
B Block Defence Colony New Delhi, 110024 South DELHI |
7827755607
mansiaggarwal208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J352||Hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine
|
In this study, the intervention will consist of individualised homoeopathic treatment prescribed on the basis of detailed case taking, analysis, evaluation, and repertorisation in accordance with Hahnemann’s guidelines (§83–§104, Organon of Medicine). The final remedy will be selected after consulting standard Homoeopathic Materia Medica, with miasmatic analysis taken into consideration where indicated Medicines will be procured from the pharmacy of Nehru Homoeopathic Medical College and Hospital, or GMP-certified sources if unavailable. Remedies will be administered in centesimal (C) or LM potencies depending on the susceptibility and clinical condition of the patient.The repetition and potency will be decided individually, based on severity of symptoms, susceptibility, and response to treatment.The total duration of the study will be 12 months, comprising two phases- Enrollment Phase in which participants will be recruited and enrolled over a period of six months.Then Follow-up Phase in which each enrolled participant will be assessed and followed up for a
period of 6 months from the date of their enrollment to evaluate clinical outcomes and treatment response.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children between 3 to 10 years of age, clinically diagnosed with adenoid hypertrophy and presenting with symptoms such as nasal obstruction, mouth breathing, or snoring, will be included in the study. Only those cases with radiological confirmation showing an Adenoid–Nasopharynx (A/N) ratio greater than 0.5 will be enrolled. Participation will be limited to children whose parents or guardians give informed consent and are willing to opt for non-surgical homoeopathic management. |
|
| ExclusionCriteria |
| Details |
Children requiring emergency adenoidectomy or those with severe complications such as obstructive sleep apnoea with an A/N ratio above 0.75 will be excluded from the study. Patients with structural abnormalities like deviated nasal septum, cleft palate, or nasal polyps, as well as those with immunodeficiency or chronic systemic illnesses, will not be included. Children with psychiatric or behavioral disorders, a previous history of adenoidectomy, or those receiving concurrent treatment from other medical systems for adenoid hypertrophy will also be excluded. Additionally, refusal to participate or non-compliance with treatment and follow-up will lead to exclusion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Adenoid–Nasopharynx (A/N) ratio on lateral nasopharyngeal X-ray
2.Nasal Obstruction Symptom Evaluation (NOSE) score |
At Baseline and after 6 months of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
13/10/2025 |
| 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="0" 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
|
Adenoid hypertrophy is a common paediatric condition leading to nasal obstruction, mouth breathing, snoring, and recurrent upper respiratory infections, with possible complications such as otitis media and obstructive sleep-disordered breathing. Homoeopathy offers a holistic, individualised, and non-invasive approach that has shown encouraging results in preliminary studies, but structured clinical evidence remains limited.
This prospective, open-label, single-arm clinical study will be conducted over 12 months at Nehru Homoeopathic Medical College and Hospital, New Delhi. A total of 40 children aged 3–10 years, clinically and radiologically diagnosed with adenoid hypertrophy (A/N ratio >0.5), will be recruited through purposive sampling. Informed consent will be obtained from parents or legal guardians before enrolment. After detailed case taking and analysis, individualised homoeopathic medicines will be prescribed in centesimal or LM potencies, selected on the basis of symptom totality, repertorisation, and standard Materia Medica. Potency and repetition adjusted according to susceptibility and clinical response.
Follow-ups will be conducted monthly for six months, with monitoring of clinical symptoms and NOSE scores. At baseline and at the 6th month, lateral nasopharyngeal X-rays will be performed to calculate the Adenoid–Nasopharynx (A/N) ratio. The primary outcome will be change in A/N ratio and NOSE score from baseline to six months. The secondary outcome will be identification of the most commonly prescribed remedies for adenoid hypertrophy in children.
Data will be documented, compiled, and analyzed statistically. Pharmacovigilance will be maintained throughout the study, with referral to higher centres if adverse events or complications arise. This study seeks to provide structured clinical evidence regarding the effectiveness and safety of individualised homoeopathic treatment as a non-invasive alternative for managing adenoid hypertrophy in children. |