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CTRI Number  CTRI/2025/09/095063 [Registered on: 18/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STUDY OF HOMEOPATHIC MEDICINES FOR CHILDREN WITH MILD TO MODERATE ADENOID PROBLEMS 
Scientific Title of Study   A Randomized Single Blind Clinical trial Comparing the efficacy of Individualized Homoeopathic Medicine versus Agraphis Nutans 6C in pediatric Adenoid Hypertrophy Grade I and Grade II. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSwapnali Dilip Patil 
Designation  PG scholar 
Affiliation  BVDUHMC 
Address  Bharati Vidyapeeth(deemed to be university)Homoeopathic Medical College and Homoeopathic Hospital,Department of postgraduate and research centre,pune.

Pune
MAHARASHTRA
411043
India 
Phone  8446790445  
Fax    
Email  swapnali.patil-hmcpune@bvp.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DrSameer SNadgauda 
Designation  Associate Professor Department of Practice of medicine  
Affiliation  BVDUHMC 
Address  Bharati Vidyapeeth(deemed to be university)Homoeopathic Medical College and Homoeopathic Hospital,Department of postgraduate and research centre,pune.

Pune
MAHARASHTRA
411043
India 
Phone  9970153078  
Fax    
Email  sameer.nadgauda@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  DrSameer SNadgauda 
Designation  Associate Professor Department of Practice of medicine  
Affiliation  BVDUHMC 
Address  Bharati Vidyapeeth(deemed to be university)Homoeopathic Medical College and Homoeopathic Hospital,Department of postgraduate and research centre,pune.

Pune
MAHARASHTRA
411043
India 
Phone  9970153078  
Fax    
Email  sameer.nadgauda@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
NILBharati Vidyapeeth (deemed to be university) homoeopathic medical College and hospital, Department of postgraduate and Research centre ,pune .411043 
 
Primary Sponsor  
Name  Dr. Swapnali Patil 
Address  Bharati Vidyapeeth (deemed to be university) homoeopathic medical College and hospital, Department of postgraduate and Research centre ,pune.411043 
Type of Sponsor  Other [self ] 
 
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 Swapnali Dilip Patil  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL  DEPT. OF POSTGRADUATE & RESEARCH CENTRE,Dhankawadi, Pune Satara Road, Pune-411043 MAHARASHTRA
Pune
MAHARASHTRA 
8446790445

swapnali.patil-hmcpune@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth(deemed to be university)Homoeopathic Medical College and Homoeopathic Hospital,Department of postgraduate and research centre,pune  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 
Comparator Agent  Agraphis Nutans 6C  As a comparator, patients will receive Agraphis nutans 6C, administered orally as 3 pills once daily at night, along with standard medical care. 
Intervention  Individualised Homoeopathic Medicine   Along with standard medical care, patients will receive an individualised homoeopathic remedy prescribed according to classical homeopathic principles, after comprehensive case-taking, repertorisation with the Synthesis Repertory, and verification with Materia Medica.Potency selection and dosage are determined on the basis of the patient’s susceptibility and clinical need. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Prediagnosed cases Grade I and Grade II Adenoid Hypertrophy.
Persistent symptoms of nasal obstruction,snoring,or mouth breathing lasting for more than 3 months. 
 
ExclusionCriteria 
Details  Previous adenoidectomy
Use of nasal corticosteroid within 1 month
Craniofacial anomalies or neuromuscular disorder
Grade III and Grade IV adenoid hypertrophy complications
Nasal polyp
Nasal obstruction due to anatomic malformations (i.e.choanal atresia or diaphragm,septal
deviations etc.) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate quality of life changes in comparative study of individualised homoeopathic medicine versus Agraphis Nutans 6C using the OSA-18 questionnaire   Quality of life assessed using the OSA-18 questionnaire at baseline and at end of 18 months study period. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of severity (mild, moderate, severe)
to compare the reduction in adenoids size between individualised homoeopathic medicines and agraphis nutans 6C  
18 months  
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 4 
Date of First Enrollment (India)   30/09/2025 
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  
Background: Adenoid hypertrophy (AH) is one of the most common pediatric ENT disorders, affecting 20–40% of children worldwide and up to 40% in India. It often leads to nasal obstruction, sleep-disordered breathing, recurrent infections, and impaired quality of life. Conventional treatments such as corticosteroids provide only temporary relief, while adenoidectomy carries risks of surgical complications and recurrence. Homeopathy, particularly Agraphis nutans, has shown potential in managing AH, but direct comparative studies with individualized homeopathic prescriptions are lacking.
Aim: To compare the efficacy of individualized homeopathic medicine with Agraphis nutans 6C in children with Grade I and Grade II adenoid hypertrophy.
Methods: This is a randomized, single-blind, controlled clinical trial conducted at Bharati Vidyapeeth Homoeopathic Medical College and Hospital, Pune. Children aged 4–12 years with Grade I or II AH confirmed by nasal endoscopy and persistent symptoms for over three months will be included. Participants will be randomized into two groups:
Group A: Individualized homeopathic medicines prescribed on the basis of totality of symptoms.
Group B: Agraphis nutans 6C, administered daily.
Primary outcome will be improvement in quality of life using the OSA-18 questionnaire. Secondary outcomes include reduction in adenoid size (via nasal endoscopy) and changes in severity scores. Data will be analyzed using appropriate statistical methods, primarily paired t-test.
Expected Outcomes:
The study seeks to generate evidence regarding the comparative effectiveness of individualized homeopathy and Agraphis nutans 6C in managing pediatric AH, offering a potential non-invasive and safe alternative to conventional therapy.
Conclusion:This trial will address the existing research gap and may guide clinicians and parents toward safer, individualized treatment strategies for pediatric adenoid hypertrophy.
 
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