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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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