Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis
| Tracking Information | |||||
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| First Received Date ICMJE | September 23, 2005 | ||||
| Last Updated Date | January 24, 2007 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Improvement in nasal symptom scores from baseline after intervention | ||||
| Original Primary Outcome Measures ICMJE |
Improvement in nasal symptom scores from baseline after intervetion | ||||
| Change History | Complete list of historical versions of study NCT00227058 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
change in cytokine profile with intervention compared to placebo | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis | ||||
| Official Title ICMJE | Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic | ||||
| 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. |
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| 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 ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
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| Condition ICMJE | Seasonal Allergic Rhinitis | ||||
| Intervention ICMJE | Drug: Orotic acid and Glutathione-(Nutritional Supplements) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | November 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00227058 | ||||
| Other Study ID Numbers ICMJE | KHK040213 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||
| Collaborators ICMJE | Kyowa Hakko Kogyo Co., Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Mississippi Medical Center | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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