| 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
|
|
|
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
|
|
|
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 |