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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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000258651 |
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Date of registration:
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01/09/2005 |
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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 antioxidant and immunomodulatory effects of Ambrotose AO in healthy smokers and non-smokers
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Scientific title:
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The antioxidant and immunomodulatory effects of Ambrotose AO in healthy smokers and non-smokers |
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Date of first enrolment:
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15/11/2004 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12605000258651.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Contacts
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Name:
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Professor Stephen Myers
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Address:
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Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Australia |
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Telephone:
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+61 2 66203403 |
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Email:
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smyers@scu.edu.au |
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Affiliation:
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Name:
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Joan O'Connor
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Address:
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Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Australia |
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Telephone:
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+61 2 66203649 |
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Email:
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joconnor@scu.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Individuals willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Exclusion criteria: 1. Individuals taking antioxidant medications and/or supplements2. Individuals with poor venous access3. Individuals with auto-immune disorders4. Individuals with diabetes5. Individuals taking immune suppressant drugs6. Individuals taking cytokine or interferon therapy7. Individuals taking Echinacea or other immune stimulating herbs8. Individuals with clinically abnormal liver function tests at baseline9. Individuals unwilling to have blood taken 9 times during the study10. Individuals unwilling to comply with the study protocols11. Individuals with any other condition which in the opinion of the researchers could compromise the study.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Antioxidant activity and immune function;
Antioxidant activity and immune function
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Inflammatory and Immune System - Normal development and function of the immune system
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Intervention(s)
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Ambrotose AO
Week 1 - Baseline 1;
Week 2 - Baseline 2;
Week 3 - 2 capsules daily;
Week 4 - 4 capsules daily
Week 5 - 8 capsules daily
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Primary Outcome(s)
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Ex vivo changes in serum oxygen radical capacity.[Measured week 3, week 4, week 5, week 6.]
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Secondary Outcome(s)
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COX 2 activity[Measured weekly]
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Phagocytosis of granulocytes and monocytes[Measured weekly]
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Urinary iPF2[Measured weekly]
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In vivo changes in lymphocyte subsets[Measured weekly]
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Source(s) of Monetary Support
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Mannatech
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Ethics review
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Status: Not approved
Approval date:
Contact:
Southern Cross University Human Research Ethics Committee
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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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