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

Phase 3

Completed

• Conditions: Human immune function; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12605000255684
• Lead Sponsor: Blackmores

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Subject is 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Mature T Cells.[Measured at baseline, baseline + 3 hours, day 13 and day 14];Ex vivo blood analysis included the assessment of changes in the lymphocyte subset B Cells.[Measured at baseline, baseline + 3 hours, day 13 and day 14];Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Helper/Inducer T Cells.[Measured at baseline, baseline + 3 hours, day 13 and day 14];Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Suppressor/Cytotoxic T Cells.[Measured at baseline, baseline + 3 hours, day 13 and day 14];Ex vivo blood analysis included the assessment of changes in the lymphocyte subset Natural Killer Cells.[Measured at baseline, baseline + 3 hours, day 13 and day 14]

Secondary Outcome Measures

Name	Time	Method
In vivo changes in the population of lymphocyte subsets.[Measured at day -1, day 1, day1 + 3 hours, day 13 and day 14.]