In vivo effects of a natural medicine formulation on human immune function
Blackmores
3 participants
Nov 1, 2002
Interventional
Conditions
Summary
Tablets were self administered by the participants for 14 days. Blood samples were drawn for laboratory analysis and safety measures (full blood count, liver function tests and serum urea, electrolytes and creatinine). Baseline blood was drawn for laboratory measures of study parameters at day 1, day1+3hours, day 13 and day 14. Blodd measured for Ex vivo blood tests Ex vivo blood analysis includes the assessment of changes in the following lymphocyte subsets: ÿ¿ÿ· Mature T cells ÿ¿ÿ· B cells ÿ¿ÿ· Helper/Inducer T cells ÿ¿ÿ· Suppressor/Cytotoxic T cells ÿ¿ÿ· Natural killer cells Assessment of changes in non-specific immune response includes: ÿ¿ÿ· Phagocytosis of granulocytes ÿ¿ÿ· Respiratory burst of granulocytes Assessment of changes in specific immune response includes: ÿ¿ÿ· Lymphocyte activation ÿ¿ÿ· Production of the following 6 cytokines: o IL-2, INFa and INFg for type 1 immune response o IL-4, IL-5 and IL-10 for type 2 immune response
Eligibility
Inclusion Criteria1
- Subject is willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Exclusion Criteria1
- Individuals with auto-immune disorders2. Individuals taking immune suppressant drugs3. Individuals taking cytokine or interferon therapy4. Individuals taking Echinacea or other immune stimulating herbs5. Individuals with clinically abnormal liver function tests at baseline6. Subjects unwilling to comply with the study protocols7. Subjects with poor venous access8. Any other condition which in the opinion of the researchers could compromise the study.
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Interventions
Beta-Glucan The subjects took 2 tablets daily one hour after breakfast. The first dose was taken on day 1 in the laboratory and the subject continued to take the medication for a further 13 days.
Locations(1)
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ACTRN12605000255684