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CompletedPhase 3ACTRN12605000255684

In vivo effects of a natural medicine formulation on human immune function

Sponsor

Blackmores

Enrollment

3 participants

Start Date

Nov 1, 2002

Study Type

Interventional

Conditions

Human immune function

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying in vivo effects of a natural medicine formulation on human immune function. You may be eligible if you are adults aged 18 to 50. People with individuals with auto-immune disorders, individuals taking immune suppressant drugs, individuals taking cytokine or interferon therapy may not be able to participate. Participation may involve medical tests, study visits, and follow-up appointments.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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)

Australia

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ACTRN12605000255684