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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orotic acid and Glutathione-(Nutritional Supplements)
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Seasonal Allergic Rhinitis focused on measuring allergic rhinitis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • University of Mississippi Medical Center

Outcomes

Primary Outcome Measures

Improvement in nasal symptom scores from baseline after intervention

Secondary Outcome Measures

change in cytokine profile with intervention compared to placebo

Full Information

First Posted
September 23, 2005
Last Updated
January 24, 2007
Sponsor
University of Mississippi Medical Center
Collaborators
Kyowa Hakko Kogyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00227058
Brief Title
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis
Official Title
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Mississippi Medical Center
Collaborators
Kyowa Hakko Kogyo Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
allergic rhinitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Orotic acid and Glutathione-(Nutritional Supplements)
Primary Outcome Measure Information:
Title
Improvement in nasal symptom scores from baseline after intervention
Secondary Outcome Measure Information:
Title
change in cytokine profile with intervention compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gailen D. Marshall, MD/PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

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

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