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CTRI Number  CTRI/2026/02/102673 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 31/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Individualised Homeopathic Treatment in management of Adenoid Hypertrophy in children  
Scientific Title of Study   Role of Individualised Homeopathic Treatment in management of Adenoid Hypertrophy in children assessed using Adenoid Obstructive Symptom Checklist: Randomised Control 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  Dr Dhanashree Jayant Bhalerao 
Designation  Ph D Scholar 
Affiliation  Dr.M.L.Dhawale Memorial Homeopathic Institute, Palghar 
Address  Dr M L Dhawale Memorial Homeopathic Institute, 306 Room No, Department of Paediatric, Opposite ST workshop Palghar-Boisar Road, Palghar
Opposite ST workshop Palghar-Boisar Road, Palghar-401404
Thane
MAHARASHTRA
401404
India 
Phone  8459779435  
Fax    
Email  bhalerao_dhanashree@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandrasekhar R Goda 
Designation  Professor  
Affiliation  Dr.M.L.Dhawale Memorial Homeopathic Institute, Palghar 
Address  Dr M L Dhawale Memorial Homeopathic Institute, 306 Room No, Department of Paediatric, Opposite ST workshop Palghar-Boisar Road, Palghar

Thane
MAHARASHTRA
401404
India 
Phone  9322882918  
Fax    
Email  sujchan18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandrasekhar R Goda 
Designation  Professor  
Affiliation  Dr.M.L.Dhawale Memorial Homeopathic Institute, Palghar 
Address  Dr M L Dhawale Memorial Homeopathic Institute, 306 Room No, Department of Paediatric, Opposite ST workshop Palghar-Boisar Road, Palghar

Thane
MAHARASHTRA
401404
India 
Phone  9322882918  
Fax    
Email  sujchan18@gmail.com  
 
Source of Monetary or Material Support  
Late Mrs. Housabai Homeopathic Medical College & Hospital, Nimshirgaon, Sangli-Kolhapur Highway,Near Dharmanagar, Tal-Shirol, Nimshirgaon Maharashtra-416101 
 
Primary Sponsor  
Name  Dr.M.L.Dhawale Memorial Homeopathic Institute, Palghar 
Address  Paediatric department, ground floor Paediatric OPD, Room No. 111, Dhawale Trust Hospital, Palghar- Boisar Road, Opposite ST workshop, Palghar 401404, Thane Maharashtra 
Type of Sponsor  Research institution and hospital 
 
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 
DrDhanashree Ashwin Kulkarni  Late Mrs Housabai Homeopathic Medical College and Hospital, Nimshirgaon  Paediatric OPD no.1,Ground Floor Nimshirgaon, Sangli Kolhapur Highway,Tal.Shirol
Kolhapur
MAHARASHTRA 
8459779435

bhalerao_dhanashree@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,MLDMHI, Palghar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Homeopathic Placebo  The placebo will be given in the form of pills. Pills will be given once a week or daily, oral route of administration for a duration of 6 months. 
Intervention  Individualized Homeopathic Remedy will be prescribed.  Individualized Homeopathic Remedy will be given after assessment of the case based on individual symptoms.Frequency and repetition can be daily dose, 3 times a day, 2 times a day, alternate day dose or weekly dose.The medicine will be administered by oral route. Medicine would be given for a period of 6 months. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Informed consent given by the parents or guardians.
Children of both the sexes in Pediatric age group from 1 year to 5 years.
Diagnosed, symptomatic cases of Adenoid Hypertrophy 
 
ExclusionCriteria 
Details  Case of adenoid hypertrophy with grade 4 obstruction on radiological evaluation.
Cranio facial anomalies congenital or acquired, diagnosed with a neuromuscular disorder, a recognized congenital syndrome, a coagulation or bleeding disorder, and or severe laryngomalacia; malignancy; tracheostomy in situ.
Children with diagnosed psychiatric illness 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the role of individualized homeopathic treatment in management of adenoid hypertrophy in children  Change in symptoms will be assessed every month for 6 months(0,1,2,3,4,5,6) using adenoid symptom checklist. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate if individualized homeopathy treatment reduces the size of Adenoids in Adenoid Hypertrophy.  X-Ray for assessing the adenoid/nasopharyngeal (A/N) ratio at 0 months and Post Treatment (at 6 months) 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   16/02/2026 
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 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  

Adenoids (nasopharyngeal tonsils), being part of Waldeyer’s ring, are masses of lymphoid tissues located at the junction of the roof and the posterior wall of the nasopharynx. Adenoids act as the first line of defence in a healthy individual protecting against microorganisms and autoimmunity. The cells of the adenoids are responsible to the priming of the immune system in infancy.

The causes of adenoid hypertrophy are not fully known. They are most likely associated with aberrant immune reactions, infections, environmental exposures and hormonal or genetic factors.

Globally, adenoid hypertrophy (AH) is one of the most prevalent upper respiratory tract disorders of children, with associated troublesome symptoms such as sleep apnea and cognitive disturbances.

An exact incidence and prevalence statistics in current available literature is not available but a meta-analysis study suggests that in a randomized representative population, the prevalence of AH was 34%.

Studies suggest that the health impact status of adenoids is significant. Literature suggests that conventional medical treatment is not able to prevent adenoidectomy and only delay it.

Though studies reveal that the quality of life improves after adenoidectomy, other studies reveal that the symptoms relief is short lasting in some while in other cases symptoms either persist or there could also be a relapse.

The role of Homeopathy in cases of Adenoids has been explored in a prospective, observational multicentric trial and has been found to play a beneficial role in the management of symptomatic AH in children.

On a literature search, two RCTs studied the efficacy of pre-determined homoeopathic medicines in adenoid hypertrophy but couldn’t

yield statistically significant results.

Hence, this RCT aims at understanding what role Individualized Homeopathic Treatment plays in cases of Adenoid Hypertrophy

 
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