An interventional study of AYURVEDA treatment protocol and Control(Citrizine 10mg) in Allergic Rhinitis (AR), sponsored by Amrita Vishwa Vidyapeetham. Not yet recruiting. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Amrita Vishwa Vidyapeetham · Not applicable, Interventional, and Treatment
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.
Allergic rhinitis is a common chronic inflammatory disorder characterized by IgE-mediated and Th2-skewed immune responses, resulting in symptoms such as sneezing, rhinorrhea, nasal obstruction, and itching. Although current therapies provide symptomatic relief, they have limited influence on upstream mechanisms involved in immune sensitization and regulation.
Emerging evidence suggests that the gut-immune axis plays an important role in allergic diseases. Alterations in gut microbial balance, intestinal permeability, and microbial-metabolic signaling have been implicated in modulation of immune responses and allergic inflammation. In addition, growing interest has focused on the gut-lung axis and its contribution to respiratory allergic disorders.
In Ayurveda, Agni is considered the fundamental regulator of digestion, metabolism, and physiological homeostasis. Disturbance of Agni is traditionally associated with impaired digestive and metabolic function and may contribute to systemic dysregulation. Contemporary research has suggested possible links between metabolic homeostasis, gut physiology, epithelial barrier integrity, and immune responsiveness, providing a potential translational framework for exploring Ayurvedic concepts in allergic disease.
This randomized controlled clinical trial is designed to evaluate the effects of an Agni-modulating Ayurvedic intervention in individuals with allergic rhinitis. The study incorporates an exploratory mechanistic component to investigate potential associations between Agni modulation, gut permeability-associated mechanisms, and Th2-mediated immune responses. Biomarker-based assessment will be used to explore changes in immune activation and gut barrier function alongside clinical outcomes.
The intervention is based on classical Ayurvedic principles of Deepana and Pachana and includes standardized Ayurvedic formulations administered under clinical supervision along with dietary regulation intended to support Agni and gut homeostasis. Participants in the control arm will receive standard conventional management.
The study is expected to generate preliminary evidence regarding the relationship between Agni modulation, gut permeability-associated mechanisms, and allergic immune responses. Findings may contribute to the development of biomarker-oriented translational approaches for understanding integrative mechanisms in allergic rhinitis and may provide a foundation for future mechanistic and personalized medicine research.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 104 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Amrita Vishwa Vidyapeetham is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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**Inclusion Criteria:**
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in the control group will receive cetirizine 10 mg bedtime for 4 weeks as defined in the study protocol.
Drug: Control(Citrizine 10mg)
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
contril group patients will be receiving the Citrizine 10 mg daily during bed time
Also known as: Citrizine
Change in Serum Immunoglobulin E (IgE) Level
Change in serum IgE concentration from Baseline to Week 4 as a marker of allergic immune response.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4
Change in Serum Interleukin-5 (IL-5) Level
Change in serum IL-5 concentration from Baseline to Week 4 as an exploratory marker of Th2-associated immune activity.
Time frame: Baseline and Week 4
Change in Serum Interleukin-13 (IL-13) Level
Change in serum IL-13 concentration from Baseline to Week 4 as an exploratory marker of allergic inflammation.
Time frame: Baseline and Week 4
Change in Lactulose-Mannitol Ratio
Change in urinary lactulose-mannitol ratio from Baseline to Week 4 as an assessment of intestinal permeability.
Time frame: Baseline and Week 4
Change in Agnibala Assessment Score
Change in Agnibala score measured using the validated Agnibala Assessment Tool. Scores range from 20 to 100, with higher scores indicating better digestive strength.
Time frame: Baseline, Week 2, and Week 4
Change in Total Nasal Symptom Score (TNSS)
Change in Total Nasal Symptom Score (TNSS). Total score ranges from 0 to 12, with higher scores indicating greater symptom severity.
Time frame: Baseline, Week 2, and Week 4
Change in Absolute Eosinophil Count
Change in peripheral blood absolute eosinophil count from Baseline to Week 4.
Time frame: Baseline and Week 4
Change in Sino-Nasal Outcome Test-20 (SNOT-20) Score
Change in SNOT-20 score. Total score ranges from 0 to 100, with higher scores indicating poorer sinonasal health-related quality of life.
Time frame: Baseline and Week 4
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Amrita Vishwa Vidyapeetham