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CTRI Number  CTRI/2025/12/099203 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to check usefulness of good bacteria in allergic running nose. 
Scientific Title of Study   Efficacy of Probiotics in Treatment of Patients with Allergic Rhinitis-A Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Boyina Harsha Vardhan  
Designation  Junior Resident  
Affiliation  Datta Meghe Institute of Higher Education and Research Centre 
Address  Department of Otorhinolaryngology,Ground floor, AVBRH building, Sawangi,Meghe

Wardha
MAHARASHTRA
442107
India 
Phone  9581184549  
Fax    
Email  harsha619vardhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shraddha Jain 
Designation  Professor and Head 
Affiliation  Datta Meghe Institute of Higher Education and Research Centre 
Address  Department of Otorhinolaryngology,Ground floor, AVBRH building, Sawangi,Meghe

Wardha
MAHARASHTRA
442107
India 
Phone  9881836366  
Fax    
Email  sjain_med@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shraddha Jain 
Designation  Professor and Head 
Affiliation  Datta Meghe Institute of Higher Education and Research Centre 
Address  Department of Otorhinolaryngology,Ground floor, AVBRH building, Sawangi,Meghe

Wardha
MAHARASHTRA
442107
India 
Phone  9881836366  
Fax    
Email  sjain_med@yahoo.co.in  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher education and Research 
Address  Sawangi Meghe, Wardha, Maharashtra, India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Boyina Harsha Vardhan  Acharya Vinoba Bhave Rural Hospital  Department of Otorhinolaryngology,Ground floor, AVBRH Building, Sawangi,Meghe
Wardha
MAHARASHTRA 		 9581184549

harsha619vardhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Combination of Levocitrizine 5 mg and Montelukast 10 mg and Fluticasone furoate nasal spray  Combination of Levocitrizine 5 mg and Montelukast 10 mg and Fluticasone furoate nasal spray will be administered in cases with allergic rhinitis. The treatment will be given for 15 days. 
Intervention  Probiotics along with Combination of Levocitrizine 5 mg and Montelukast 10 mg and Fluticasone furoate nasal spray will be administered in cases with allergic rhinitis  Combination of Levocitrizine 5 mg and Montelukast 10 mg and Fluticasone furoate nasal spray along with oral probiotic supplements will be administered in cases with allergic rhinitis. The treatment will be given for 15 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with moderate and severe persistent allergic rhinitis as per ARIA guidelines
2. Patients consenting for study 
 
ExclusionCriteria 
Details  1. Grossly deviated nasal septum
2. Patients with acute and chronic rhinosinusits
3. Patients with mild and intermittent AR as per ARIA guidelines
4. Patients with adenoid hypertrophy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The change in tnss from pre to post treatment was used as primary outcome to assess the efficacy of probiotics in reducing allergic rhinitis  Assessments will be done at 2 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/01/2026 
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="2"
Months="6"
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  

This study evaluates the effectiveness of probiotic supplementation as an adjunct to standard therapy in patients with allergic rhinitis. Allergic rhinitis is a common condition that significantly affects quality of life, and although standard treatments relieve symptoms, they do not modify the underlying immune response. Probiotics, particularly Lactobacillus strains, have shown potential immunomodulatory effects by shifting the Th2-dominant allergic response toward a more balanced Th1/Th2 profile. In this double-blind randomized controlled trial, 46 patients aged 18–70 will be assigned to receive either standard ARIA-guided treatment alone or standard therapy plus probiotics for 15 days. Outcomes—including symptom scores, quality of life, and inflammatory markers such as IL-5, IL-13, and Th1/Th2 ratio—will be compared to determine whether probiotics provide additional clinical benefit and immune modulation in managing allergic rhinitis.

 
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