| CTRI Number |
CTRI/2025/10/095539 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homeopathy in the treatment of allergic rhinitis in children |
|
Scientific Title of Study
|
Effect of Constitutional Medicine in the Management of Cases of Allergic Rhinitis in Children 4 to 16 Years A Prospective Single Arm Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surbhi Kumari |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no g20
Department of Paediatrics
Ground floor
Plot No 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9773926515 |
| Fax |
|
| Email |
rollyk828@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Garg |
| Designation |
Professor and Head of the Department Department of Paediatrics |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no g20
Department of Paediatrics
Ground floor
Plot No 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
09411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
Professor and Head of the Department Department of Paediatrics |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no g20
Department of Paediatrics
Ground floor
Plot No 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
09411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
Plot No 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh India
201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Bakson Homoeopathic Medical College and Hospital
Room no G22
Principal Office
Ground Floor
Plot No 36B
Knowledge Park phase 1
Greater Noida
Uttar Pradesh 201306 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surbhi Kumari |
Bakson Homoeopathic Medical College and Hospital |
Outpatient Department
Room No 1
Ground Floor
36 B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh
201306
Gautam Buddha Nagar
UTTAR PRADESH |
09773926515
rollyk828@gmail.com |
| Dr Surbhi Kumari |
Dr D P Rastogi Central Research Institute Homoeopathy |
Outpatient Department 110
Ground floor
A-1/1 Opposite HCL
Sector 24
Noida
Uttar Pradesh
201307
Gautam Buddha Nagar
UTTAR PRADESH |
09773926515
rollyk828@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J30||Vasomotor and allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicine |
Pill Form of Administration
Oral route of Administration
30 Pill size
Centesimal Scale
First dose after initial case taking
Repetition of dose according to follow up every 4 weeks for 24 weeks |
| Comparator Agent |
Not Applicable |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children with age group 4 to 16 years irrespective of their religion and gender
Participant clinically diagnosed of mild to moderate cases of allergic rhinitis based on ARIA guidelines
Participant who has not taken anti allergic medications for at least 2 weeks prior
to enrollment
Participants willing to giving permission to enroll for the study |
|
| ExclusionCriteria |
| Details |
Participants with severe systemic illness any immuno-compromised condition any psychiatric issues under any substance abuse and severe endocrine disorders
Participant already under long-term antihistamines corticosteroids or immunotherapy
Participant with psychiatric disorders or cognitive impairment affecting their ability to give consent and assent or adhere to protocol
Participant with nasal polyps deviated nasal septum chronic sinusitis asthma
Participant already participating in another clinical trials |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the result of Constitutional Homoeopathic Treatment of Allergic Rhinitis in Paediatric age group using
Control of Allergic Rhinitis and Asthma Test scores before and after the Homoeopathic Treatment |
16 Months Study
6 Months Enrollment
6 Months Follow up
2 Months Report writing
2 Months Data analysis
Statistical analysis to be done at Baseline 3 Month and 6 Month for scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
12/10/2025 |
| 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="4"
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
|
This study aims to know the role of Constitutional Homoeopathic Medicine in the Management of cases of Allergic Rhinitis in children aged 4 to 16 years in which 35 cases will be enrolled irrespective of gender and Control of Allergic Rhinitis and Asthma test Score will be filled at Baseline 3 Month and 6 Month and Outcomes will be statistically assessed with Repeated Measure ANOVA |