EFFECT OF AYURVEDA TREATMENT IN ALLERGIC RHINITIS

Summary

Background Allergic Rhinitis is a chronic Th2-mediated inflammatory disorder associated with significant disease burden and impaired quality of life. Emerging evidence highlights the role of the gut-immune axis, intestinal permeability, and microbial-metabolic signaling in modulation of allergic immune responses. In , Agni is considered the fundamental regulator of digestion, metabolism, and physiological homeostasis. Disturbance in Agni may contribute to altered gut homeostasis and immune dysregulation. However, the relationship between Agni, gut permeability-associated mechanisms, and Th2-mediated immune response in allergic rhinitis remains insufficiently explored.

Aim To evaluate the effect of an Agni-modulating Ayurvedic intervention on Th2-mediated immune response and gut permeability-associated mechanisms in individuals with allergic rhinitis.

Objectives The primary objective is to evaluate the effect of an Agni-modulating Ayurvedic intervention on serum immunoglobulin E (IgE) and interleukin-4 (IL-4) levels in allergic rhinitis. Secondary objectives include assessment of gut permeability-associated biomarkers including serum zonulin and lactulose-mannitol test parameters, evaluation of changes in Agni status and clinical symptom severity, and exploration of associations between Agni status, gut permeability-associated biomarkers, and immune response. The study also aims to explore inter-individual variability based on Agni types and Prakriti.

Methods This study is designed as a randomized, controlled, assessor-blinded, parallel-group clinical trial with an embedded exploratory mechanistic component. A total of 104 participants aged 18-60 years diagnosed with allergic rhinitis based on standard clinical criteria and positive skin prick test will be recruited and randomized in a 1:1 ratio into intervention and control groups. The intervention group will receive a standardized Agni-modulating Ayurvedic treatment protocol consisting of Deepana-Pachana formulations followed by Amrita Ghritham along with Pathya-Apathya advice, in addition to standard conventional management. The control group will receive standard conventional management. Primary outcome measures include serum IgE, IL-4, serum zonulin, and lactulose-mannitol test parameters. Secondary outcomes include Agni assessment, Total Nasal Symptom Score (TNSS), eosinophil count, and subgroup analysis based on Agni and Prakriti.

Expected Outcome The study is expected to provide preliminary evidence regarding the relationship between Agni modulation, gut permeability-associated mechanisms, and Th2-mediated immune response in allergic rhinitis, and may contribute to biomarker-oriented translational and integrative approaches in allergic disease management.

Conditions

• Allergic Rhinitis (AR)

Interventions

OTHER

AYURVEDA treatment protocol

The intervention protocol will include administration of selected classical Ayurvedic formulations, including ghrita-based and fermented preparations, along with dietary regulation (Pathya-Apathya) intended to support Agni and gut homeostasis. The treatment protocol will be standardized with respect to formulation, dosage, frequency, duration, and method of administration, and will be implemented under clinical supervision throughout the study period.

DRUG

Control(Citrizine 10mg)

contril group patients will be receiving the Citrizine 10 mg daily during bed time

Sponsors & Collaborators

• Amrita Vishwa Vidyapeetham

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2028-06-30

Primary Completion

2029-12-30

Completion

2030-12-30