| CTRI Number |
CTRI/2025/07/090835 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe the role of homoeopathic medicines after intervention in case of allergic nasal symptoms in paediatric patients |
|
Scientific Title of Study
|
Role of Homoeopathic medicines in management of Allergic rhinitis in Paediatric age group - A clinical observational 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 Kamal Nainawat |
| Designation |
PG Scholar |
| Affiliation |
Dr. MPK Homoeopathic Medical College Hospital and Research Centre, Homoeopathy University |
| Address |
Department Of Paediatrics
Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Plot no 10,11,12 Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
7740991696 |
| Fax |
|
| Email |
kamalnainawat15796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasoon Choudhary |
| Designation |
Professor and HOD Department of Paediatrics |
| Affiliation |
Dr. MPK Homoeopathic Medical College Hospital and Research Centre, Homoeopathy University |
| Address |
Department Of Paediatrics
Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Plot no 10,11,12 Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414718100 |
| Fax |
|
| Email |
drprasoonchoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Nainawat |
| Designation |
PG Scholar |
| Affiliation |
Dr. MPK Homoeopathic Medical College Hospital and Research Centre, Homoeopathy University |
| Address |
Department Of Paediatrics
Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Plot no 10,11,12 Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
7740991696 |
| Fax |
|
| Email |
kamalnainawat15796@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics Dr Girenra Pal Homoeopathic Hospital and Research Centre A Collegiate Hospital of Dr. MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Plot no 10,11,12 Saipura Sanganer Jaipur |
| Type of Sponsor |
Private medical college |
|
|
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 Kamal Nainawat |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Paediatrics, Room no 9, Unit 2, Dr MPK Homoeopathic Medical College, Hospital and Research Centre, Homoeopathy University, Plot no 10,11,12 Saipura Sanganer Jaipur
Jaipur
RAJASTHAN |
7740991696
kamalnainawat15796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Oral administration of individualized homoeopathic medicine of 6C, 30C, 200C, 1M, 10M, 50M, CM with proper dose and repetition and followed after as per need of the case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Nose: sneezing, nasal congestion or blockage, nasal discharge (runny nose),
and a scratchy palate and nose.
2. Eye: red eyes (concomitant allergic conjunctivitis), swollen eyes, and bilateral itching eyes
|
|
| ExclusionCriteria |
| Details |
1. Individuals who decline to consent to the study.
2. Patients who have been diagnosed with additional autoimmune and systemic diseases.
3. The situations that call for rescue or emergency care.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Homeopathic Medicines in cases of Allergic rhinitis by comparing the pre- and post- scores of Sino Nasal Outcome Test (SNOT-22). |
Pre score will be taken at the baseline of
treatment and post scores will be assessed at
the end of 3 months using Sino Nasal Outcome Test (SNOT-22) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any changes in IgE level. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/07/2025 |
| 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="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
|
To manage the role of individualized homoeopathic medicine in cases of allergic rhinitis.• Null Hypothesis (H0) – Homoeopathic medicines are not effective in managing cases of Allergic Rhinitis in paediatric age group. • Alternate hypothesis (H1) – Homoeopathic medicines are effective in managing cases of Allergic Rhinitis in paediatric age group. |