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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02463318 |
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Date of registration:
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02/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
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Scientific title:
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Date of first enrolment:
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September 2012 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02463318 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Solaleh Emamgholipour, PhD Student |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tehran University of Medical Sciences |
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Name:
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Mohammad Ali Sahraian, Neurologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the
McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability
Status Scale (EDSS) score = 6 and had never received immunomodulatory and immunosuppressive
drugs.
Exclusion Criteria:
- The exclusion criteria were as follows: 1) treated with antioxidant supplements,
anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of
acute or chronic infection, malignancy, diabetes (type I and II), and any clinically
significant systemic disease; 3) was currently pregnant or lactating; 4) was currently
smoking; 5) used contraceptive medication during the previous 6 months.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Oxidative Stress
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Multiple Sclerosis
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Intervention(s)
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Other: Hydrogen peroxide
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Drug: Melatonin
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Primary Outcome(s)
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Relative gene expression by real-time PCR (polymerase chain reaction)
[Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2]
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Secondary Outcome(s)
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MnSOD enzyme activity assay
[Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2]
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SIRT1 enzyme activity assay
[Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2]
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Catalse enzyme activity assay
[Time Frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2]
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Secondary ID(s)
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91-01-30-17019
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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