Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if two nutritional supplements, Orotic Acid and Glutathione will have any effect on the immune system response and if there will be any effect on the symptoms of seasonal allergies. It is our thinking that they will have an positive effect.

Detailed Description
-----------------
Current therapy for most immune-based diseases center around the use of anti inflammatory agents, many of which have unpleasant or dangerous side effects. Allergic rhinitis affects over 40 million Americans and its morbidity results from a combination of physical and psychological symptoms. The primary immunopathology has been defined as an imbalance of TH1/TH2 cytokines production resulting in increased allergen-specific IgE production, mast cell activation and eosinophil recruitment/activity. Metallic salts of orotic acid (OR), a natural intermediate in pyrimidine nucleic acid synthesis have been utilized to improve the signs and symptoms of a variety of maladies including the common cold, allergies and as preventatives for cancer and heart disease. Recent studies have reported that moderate doses of OR can mitigate or prevent endocrine and subjective psychological stresses in an acute laboratory stress model. All these findings lead us to hypothesize that OR salts administration will alleviate or eliminate the signs and symptoms associated with seasonal AR through a protective effect that involves direct anti-inflammatory immune effects and/or immunomodulation that include leukocyte trafficking, immunoregulatory cytokine balance and/or decrease inflammatory cell activity.

Official Title
-----------------
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Orotic acid and Glutathione-(Nutritional Supplements)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have allergic rhinitis and be skin test positive to Bermuda Grass, Johnson grass, oak tree and/or ragweed, be symptomatic - Exclusion Criteria: Any significant known heath disease: cardiovascular disease, cancer, or any metabolic disorder, smoker -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Orotic acid and Glutathione-(Nutritional Supplements)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in nasal symptom scores from baseline after intervention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cytokine profile with intervention compared to placebo |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic rhinitis