| CTRI Number |
CTRI/2025/03/082673 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding relationship between Ayurvedic biological factor Agni and serum IgE in children with Recurrent upper respiratory tract infections |
|
Scientific Title of Study
|
An observational study to assess the relationship between status of Agni and serum IgE in children with Recurrent Upper Respiratory Tract Infections(R-URTI) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARYA K |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda college, Pariyaram, Kannur |
| Address |
Department of Roga Nidana Government Ayurveda college Pariyaram, Kannur,Kerala, 670503
Kannur
KERALA
670503
India |
| Phone |
8289850360 |
| Fax |
|
| Email |
aryakarippala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Farseena K |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurveda college, Pariyaram, Kannur |
| Address |
Department of Roga Nidana Government Ayurveda college Pariyaram, Kannur,Kerala, 670503
Kannur
KERALA
670503
India |
| Phone |
9995744141 |
| Fax |
|
| Email |
drfarziaman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARYA K |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda college, Pariyaram, Kannur |
| Address |
Department of Roga Nidana Government Ayurveda college Pariyaram, Kannur,Kerala, 670503
Kannur
KERALA
670503
India |
| Phone |
8289850360 |
| Fax |
|
| Email |
aryakarippala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Pariyaram, Kannur,670503, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Pariyaram, Kannur |
| Address |
Government Ayurveda College Pariyaram, Kannur,670503, Kerala, India |
| Type of Sponsor |
Other [Government Ayurveda 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 |
| ARYA K |
Government Ayurveda college Hospital Pariyaram,Kannur |
Department of Roganidana
Room number-7
Kannur
KERALA |
8289850360
aryakarippala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government Ayurveda College,Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group having Recurrent Upper Respiratory Tract Infection of both genders, as per the diagnostic criteria attending OPD and IPD of Govt. Ayurveda college hospital, Kannur |
|
| ExclusionCriteria |
| Details |
children having serious respiratory illness |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| the relationship between status of Agni and serum IgE in children with Recurrent Upper Respiratory Tract Infection, will be assessed statistically |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
18/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This cross-sectional observational study assessed the relationship between the status of Agni and serum IgE levels among 39 children aged 5–16 years with recurrent upper respiratory tract infections (R-URTI). The findings revealed a significant association between Agni status and serum IgE levels in these children. As serum IgE levels increased, the condition of Agni progressively worsened. Mandagni was found to be predominant among children with very high IgE levels, whereas Vishamagni predominated in children with moderately elevated IgE levels, followed by Mandagni. These findings suggest that Agnidushti plays a major role in the occurrence of recurrent respiratory infections in children. The study highlights the fundamental role of Agni in maintaining health, as its derangement may compromise immunity and contribute to the recurrence of infections. |