| CTRI Number |
CTRI/2025/01/079358 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring the Effectiveness of Synbiotics in Treating Allergic Rhinitis |
|
Scientific Title of Study
|
Unveiling the potential of symbiotics in
allergic rhinitis treatment: A multi-arm
double blinded randomized 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 |
Smitha Chandra B C |
| Designation |
Associate Professor |
| Affiliation |
Department of ENT & HNS |
| Address |
PES University Institute of Medical Sciences & Research, PES university, Electronic City, Bangalore.
Bangalore
KARNATAKA
560100
India |
| Phone |
7259511715 |
| Fax |
|
| Email |
smithachandra10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha Chandra B C |
| Designation |
Associate Professor |
| Affiliation |
Department of ENT & HNS |
| Address |
PES University Institute of Medical Sciences & Research, PES University, Electronic City, Bengaluru
Bangalore
KARNATAKA
560100
India |
| Phone |
7259511715 |
| Fax |
|
| Email |
smithachandra10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smitha Chandra B C |
| Designation |
Associate Professor |
| Affiliation |
Department of ENT & HNS |
| Address |
PES University Institute of Medical Sciences & Research, PES University, Electronic City, Bengaluru
Bangalore
KARNATAKA
560100
India |
| Phone |
7259511715 |
| Fax |
|
| Email |
smithachandra10@gmail.com |
|
|
Source of Monetary or Material Support
|
| PES University Institute of Medical Sciences & Research, PES University, Electronic City, Bengaluru - 560100 |
|
|
Primary Sponsor
|
| Name |
PES University Institute of Medical Sciences Research |
| Address |
PES University Institute of Medical Sciences & Research, PES University, Electronic City, Bengaluru |
| 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 Smitha Chandra |
PES University Institute of Medical Sciences & Research |
Department of ENT & HNS, PES University Institute of Medical Sciences & Research, PES University, Electronic City, Bengaluru
Bangalore
KARNATAKA |
7259511715
smithachandra10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (Registration No EC/NEW/INST/2023/4169) |
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 |
| Comparator Agent |
Prebiotics & Probiotics |
Prebiotics in the oral formulation for 3 months
Probiotics in the oral formulation for 3 months |
| Intervention |
Synbiotics |
Synbiotics (Pre + Probiotics) in oral formulation for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who are aged above 18 years.
2. Individuals suffering from perennial allergic rhinitis.
3. Participants who are willing to participate. |
|
| ExclusionCriteria |
| Details |
1. Individuals with nasal polyposis.
2. Participants with concurrent comorbidities.
3. Migrants to the place of study who migrated less than an year ago. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Allergic symptoms assessed using SNOT 20, Absolute Eosinophilic count and IgE levels. |
Participants will be assessed at 1, 3 and 6 months duration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AEC Ige counts will reduce |
measured at 3rd and 6th month |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
03/02/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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)
|
The study is being conducted in our department. Around 50 cases have been recruited into the study and randomized into 3 groups. patients have been well informed about the study and recruited after obtaining their consent. these patients are followed up and their assessment is being done regularly. |