- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00227058
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis
January 24, 2007 updated by: University of Mississippi Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Improvement in nasal symptom scores from baseline after intervention
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Secondary Outcome Measures
Outcome Measure |
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change in cytokine profile with intervention compared to placebo
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gailen D. Marshall, MD/PhD, University of Mississippi Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
September 23, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (Estimate)
September 27, 2005
Study Record Updates
Last Update Posted (Estimate)
January 26, 2007
Last Update Submitted That Met QC Criteria
January 24, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHK040213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Seasonal Allergic Rhinitis
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Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
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UCB PharmaCompletedRhinitis | Allergic | Seasonal
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SanofiCompleted
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Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
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SanofiCompleted
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BayerCompletedRhinitis | Seasonal Rhinitis
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GlaxoSmithKlineCompletedRhinitis, Allergic, Perennial and SeasonalUnited States
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University of East AngliaNorfolk and Norwich University Hospitals NHS Foundation Trust; Quadram Institute... and other collaboratorsCompletedAsthma | Grass Allergy | Seasonal Affective RhinitisUnited Kingdom
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ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
Clinical Trials on Orotic acid and Glutathione-(Nutritional Supplements)
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Spanish Society of CardiologyRecruiting
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Clark BishopCompletedCystic FibrosisItaly
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Olympic Seafood ASCompletedAdverse Drug Event | Side Effects of DrugsFinland
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Changzheng-CinkateTerminatedViremia | ViruriaUnited States
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Johns Hopkins Bloomberg School of Public HealthJohns Hopkins University; United States Agency for International Development... and other collaboratorsCompletedPregnancy | Low Birth Weight | Infant Mortality | Nutritional Status
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University Hospital, BordeauxMinistry of Health, France; Ligue contre le cancer, FranceCompleted