| 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
|
|
|
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
|
|
|
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. |