CTRI

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CTRI Number

CTRI/2025/06/088665 [Registered on: 12/06/2025] Trial Registered Prospectively

Last Modified On:

07/11/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Studying the Effectiveness of Probiotic Supplementation in patients with Allergic Rhinitis: A Randomized Controlled Trial

Scientific Title of Study

Investigating the Efficacy of Probiotic Supplementation in the Management of Allergic Rhinitis: A Randomized Controlled 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 Bhairavi Sharma
Designation	Post Graduate
Affiliation	Aarupadai Veedu Medical College and Hospital
Address	OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam OPD number 9 OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry PONDICHERRY 607402 India
Phone	9819814438
Fax
Email	bhairavisharma98@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sowmya Gajapathy
Designation	Assistant Professor
Affiliation	Aarupadai Veedu Medical College and Hospital
Address	OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry PONDICHERRY 607402 India
Phone	8072351531
Fax
Email	sowmya.rengaraj@avmc.edu.in

Details of Contact Person
Public Query

Name	Dr Sowmya Gajapathy
Designation	Assistant Professor
Affiliation	Aarupadai Veedu Medical College and Hospital
Address	OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam PONDICHERRY 607402 India
Phone	8072351531
Fax
Email	sowmya.rengaraj@avmc.edu.in

Source of Monetary or Material Support

Aarupadai Veedu medical college and hospital Kirumampakkam Kirumampakkam Pondicherry 607402

Primary Sponsor

Name	Arupadai Veedu Medical College and Hospital
Address	Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry 607402
Type of Sponsor	Research institution and hospital

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 Bhairavi Sharma	Aarupadai Veedu Medical College and Hospital	OPD number 9 Department of Otorhinolaryngology Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry PONDICHERRY	9819814438 bhairavisharma98@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethical Committee	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
Intervention	Combination of Lactic acid bacillus, Nicotinamide, and Pyridoxine hydrochloride	Along with standard drugs probiotics will be administered orally once a day for 6 weeks
Comparator Agent	standard drug	Only standard drugs will be given to the patient according to standard dosage orally for 6 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	Patients aged 18 upto 50 years attending ENT OPD in AVMC presenting with symptoms of allergic rhinitis with blood investigations supporting the diagnosis of allergic rhinitis.

ExclusionCriteria

Details

Patients with a history of severe allergic reactions or other significant comorbidities.
Patients currently using probiotics or undergoing immunomodulatory therapy.
Pregnant or lactating women.
Patients previously diagnosed with GERD

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
To asses Effectiveness of reducing symptoms and immunology marker levels .i.e. AEC count and Ige and diagnostic nasal endoscopy using probiotics as an adjunct with standard treatment for patients having Allergic Rhinitis.	To asses Effectiveness of reducing symptoms and immunology marker levels at 2 weeks , 4 weeks ,6 weeks

Secondary Outcome

Outcome	TimePoints
To establish the association of Laryngeal reflux/Gastro- oesophageal reflux with allergic rhinitis.	at 2 weeks , 4 weeks ,6 weeks

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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)

23/06/2025

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)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
Who will be able to view these files?
Response - Anyone

For what types of analyses will this data be available?
Response - Any purpose.

By what mechanism will data be made available?
Response - Proposals should be directed to [otorhinolaryngology@avmc.edu.in].

For how long will this data be available start date provided 14-01-2026 and end date provided 14-01-2027?
Response - Immediately following publication. No end date.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil

Brief Summary

Allergic rhinitis is a common inflammatory condition of the nasal mucosa, characterized by symptoms such as nasal congestion, rhinorrhoea, sneezing, and nasal itching, often triggered by allergens. It affects a noteworthy portion of the population worldwide, leading to impaired quality of life, productivity losses, and substantial healthcare costs. The current standard treatments for allergic rhinitis include antihistamines, intranasal corticosteroids, and allergen immunotherapy.

Recent research has increasingly focused on the role of the gut microbiota in modulating immune responses and inflammatory conditions, including allergic diseases.

Probiotics, are defined as live microorganisms that offer health benefits when administered in adequate amounts.

Several studies have suggested that specific probiotic strains can promote immune tolerance and reduce allergic responses.

Despite the promising evidence we have failed to document the evidence of the use of probiotics in individuals with allergic rhinitis in the area specific to Pondicherry and Cuddalore of Tamil Nadu.

This study aims to contribute to the growing body of evidence by conducting a randomized controlled trial to investigate the impact of probiotics on allergic rhinitis symptoms and immune markers.

Aim - To asses Effectiveness of reducing symptoms and immunology marker levels .i.e. AEC count and Ige using probiotics as an adjunct with standard treatment for patients having Allergic Rhinitis.