Allergic Rhinitis (AR)ARAMNCT07626099
EFFECT OF AYURVEDA TREATMENT IN ALLERGIC RHINITIS
A study testing AYURVEDA treatment protocol in people with Allergic Rhinitis (AR), run by Amrita Vishwa Vidyapeetham.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Allergic Rhinitis (AR)
- What is being tested?
- AYURVEDA treatment protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2028to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Severe psychiatric illness.
- Inability to comply with study procedures.
- Current participation in another clinical trial.
About this study
Official title: EFFECT OF AN AGNI-MODULATING AYURVEDIC INTERVENTION ON GUT PERMEABILITY AND TH2-MEDIATED IMMUNE BIOMARKERS IN ALLERGIC RHINITIS: A RANDOMIZED CONTROLLED TRIAL PROTOCOL
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Allergic Rhinitis (AR)
- Being tested
- AYURVEDA treatment protocol, Control(Citrizine 10mg)
- Keywords
- allergic rhinitis, agni, ayurveda, gut-immune axis, Th2 immunity, IgE, Serum Zonulin, Lactose-Mannitol test
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYURVEDA treatment protocolOther
Also called VAISHWANARAM CHOORNAM, VISHA VILWADY GUTIKA, AMRITA GHRITHM, SURASASAVAM
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.
Control(Citrizine 10mg)Drug
Also called Citrizine
contril group patients will be receiving the Citrizine 10 mg daily during bed time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Control(Citrizine 10mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Immunoglobulin E (IgE) Level
Change in serum IgE concentration from Baseline to Week 4 as a marker of allergic immune response.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, and Week 4
Change in Absolute Eosinophil Count
Change in peripheral blood absolute eosinophil count from Baseline to Week 4.
Measured: 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 Jun 2028 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis (AR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amrita Vishwa Vidyapeetham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Preethi Mohan, Amrita Vishwa Vidyapeetham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626099
- Sponsor's protocol ID
- RHINITIS PROTOCOL 2026
- Acronym
- ARAM
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF AN AGNI-MODULATING AYURVEDIC INTERVENTION ON GUT PERMEABILITY AND TH2-MEDIATED IMMUNE BIOMARKERS IN ALLERGIC RHINITIS: A RANDOMIZED CONTROLLED TRIAL PROTOCOL
- ClinicalTrials.gov ID
- NCT07626099
- Acronym / sponsor ID
- ARAM / RHINITIS PROTOCOL 2026
- Conditions
- Allergic Rhinitis (AR)
- Keywords
- allergic rhinitis, agni, ayurveda, gut-immune axis, Th2 immunity, IgE, Serum Zonulin, Lactose-Mannitol test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Amrita Vishwa VidyapeethamUniversity, hospital or other
- Study start
- 30 Jun 2028 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AYURVEDA | Experimental | Other: AYURVEDA treatment protocolParticipants 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. |
| CONTROL | Active comparator | Drug: Control(Citrizine 10mg)Participants in the control group will receive cetirizine 10 mg bedtime for 4 weeks as defined in the study protocol. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AYURVEDA treatment protocolAlso: VAISHWANARAM CHOORNAM, VISHA VILWADY GUTIKA, AMRITA GHRITHM, SURASASAVAMThe 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 |
| Control(Citrizine 10mg)Also: Citrizinecontril group patients will be receiving the Citrizine 10 mg daily during bed time | Drug | CONTROL |
Primary outcome
Change in Serum Immunoglobulin E (IgE) Level
Time frame: Baseline and Week 4
Change in serum IgE concentration from Baseline to Week 4 as a marker of allergic immune response.
Change in Serum Interleukin-4 (IL-4) Level
Time frame: Baseline and Week 4
Change in serum IL-4 concentration from Baseline to Week 4 as a marker of Th2-mediated immune response.
Change in Serum Zonulin Level
Time frame: Baseline and Week 4
Change in serum zonulin concentration from Baseline to Week 4 as a surrogate biomarker associated with intestinal permeability.
7 secondary outcomes
Change in Serum Interleukin-5 (IL-5) Level
Time frame: Baseline and Week 4
Change in Serum Interleukin-13 (IL-13) Level
Time frame: Baseline and Week 4
Change in Lactulose-Mannitol Ratio
Time frame: Baseline and Week 4
Change in Agnibala Assessment Score
Time frame: Baseline, Week 2, and Week 4
Change in Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Week 2, and Week 4
Change in Absolute Eosinophil Count
Time frame: Baseline and Week 4
Change in Sino-Nasal Outcome Test-20 (SNOT-20) Score
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AYURVEDA treatment protocol in people with Allergic Rhinitis (AR), run by Amrita Vishwa Vidyapeetham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Immunoglobulin E (IgE) Level (time frame: Baseline and Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.