EFFECT OF AYURVEDA TREATMENT IN ALLERGIC RHINITIS

NCT07626099 | Not Yet Recruiting DMC

• 1 other identifier: RHINITIS PROTOCOL 2026
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

allergic rhinitis; agni; ayurveda; gut-immune axis; Th2 immunity; IgE; Serum Zonulin; Lactose-Mannitol test

Outcome Measures

Primary Outcomes (3)

• Change in Serum Immunoglobulin E (IgE) Level

  Change in serum IgE concentration from Baseline to Week 4 as a marker of allergic immune response.

  Baseline and Week 4

• Change in Serum Interleukin-4 (IL-4) Level

  Change in serum IL-4 concentration from Baseline to Week 4 as a marker of Th2-mediated immune response.

  Baseline and Week 4

• Change in Serum Zonulin Level

  Change in serum zonulin concentration from Baseline to Week 4 as a surrogate biomarker associated with intestinal permeability.

  Baseline and Week 4

Secondary Outcomes (7)

• Change in Serum Interleukin-5 (IL-5) Level

  Baseline and Week 4

• Change in Serum Interleukin-13 (IL-13) Level

  Baseline and Week 4

• Change in Lactulose-Mannitol Ratio

  Baseline and Week 4

• Change in Agnibala Assessment Score

  Baseline, Week 2, and Week 4

• Change in Total Nasal Symptom Score (TNSS)

  Baseline, Week 2, and Week 4

Study Arms (2)

AYURVEDA

EXPERIMENTAL

Participants allocated to the intervention group will receive a standardized Agni-modulating Ayurvedic treatment protocol based on the principles of Deepana and Pachana, aimed at restoration of digestive and metabolic homeostasis. 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.

Other: AYURVEDA treatment protocol

CONTROL

ACTIVE COMPARATOR

Participants in the control group will receive cetirizine 10 mg bedtime for 4 weeks as defined in the study protocol.

Drug: Control(Citrizine 10mg)

Interventions

AYURVEDA treatment protocol OTHER

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.

Also known as: VAISHWANARAM CHOORNAM, VISHA VILWADY GUTIKA, AMRITA GHRITHM, SURASASAVAM

AYURVEDA

Control(Citrizine 10mg) DRUG

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

Also known as: Citrizine

CONTROL

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants aged 18-40 years.
• Clinical diagnosis of Allergic Rhinitis based on standard diagnostic criteria.
• Positive skin prick test to relevant allergens.
• Presence of active allergic rhinitis symptoms at the time of recruitment.
• Willingness to participate and provide written informed consent.
• Willingness to comply with study procedures, laboratory investigations, and follow-up assessments.

You may not qualify if:

• Severe systemic illness.
• Immunodeficiency disorders.
• Autoimmune diseases.
• Chronic gastrointestinal disorders that may influence gut permeability parameters.
• Other chronic inflammatory conditions that may influence immune response.
• Long-term immunosuppressive therapy.
• Systemic corticosteroid therapy.
• Biologic therapy.
• Use of medications known to significantly alter immune response or gut microbiota.
• Use of antibiotics within the previous 3 months.
• Use of probiotics within the previous 3 months.
• Use of prebiotics within the previous 3 months.
• Pregnancy.
• Lactation.
• Known food allergy or hypersensitivity to study medications.

Sponsors & Collaborators

• Amrita Vishwa Vidyapeetham: lead

Related Links

• Related Info

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Amrita School Of Ayurveda

Model Details: This study is designed as a randomized, controlled, parallel-group clinical trial with an embedded exploratory mechanistic component to evaluate the association between Agni modulation, gut permeability-associated mechanisms, and Th2-mediated immune response in individuals with allergic rhinitis.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): June 30, 2028
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: June 4, 2026

Record last verified: 2026-05