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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00227058
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : January 26, 2007
Kyowa Hakko Kogyo Co., Ltd.
Information provided by:
University of Mississippi Medical Center

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Orotic acid and Glutathione-(Nutritional Supplements) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic
Study Start Date : January 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Primary Outcome Measures :
  1. Improvement in nasal symptom scores from baseline after intervention

Secondary Outcome Measures :
  1. change in cytokine profile with intervention compared to placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00227058

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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Kyowa Hakko Kogyo Co., Ltd.
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Principal Investigator: Gailen D. Marshall, MD/PhD University of Mississippi Medical Center
Layout table for additonal information Identifier: NCT00227058    
Other Study ID Numbers: KHK040213
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007
Keywords provided by University of Mississippi Medical Center:
allergic rhinitis
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases