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

This study has been completed.
Sponsor:
Collaborator:
Kyowa Hakko Kogyo Co., Ltd.
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00227058
First received: September 23, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 23, 2005
January 24, 2007
January 2005
Not Provided
Improvement in nasal symptom scores from baseline after intervention
Improvement in nasal symptom scores from baseline after intervetion
Complete list of historical versions of study NCT00227058 on ClinicalTrials.gov Archive Site
change in cytokine profile with intervention compared to placebo
Same as current
Not Provided
Not Provided
 
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Seasonal Allergic Rhinitis
Drug: Orotic acid and Glutathione-(Nutritional Supplements)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2005
Not Provided

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

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Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227058
KHK040213
Not Provided
Not Provided
University of Mississippi Medical Center
Kyowa Hakko Kogyo Co., Ltd.
Principal Investigator: Gailen D. Marshall, MD/PhD University of Mississippi Medical Center
University of Mississippi Medical Center
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP