Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
Main aim: Examine whether daily oral ingestion of a immunomodulatory mushroom extract
(AndoSanTM) leads to a clinical, biochemical and genetical improvement in RA. The experiment
will be carried out for 21 days in 15 eligible RA patients. In order to increase the
scientific value of the project we will use, a as far as possible, an age matched control
group of RA patients with steady medication and no intervention. The control group of 10-15
patients will be answering the same questionnaires and give the same samples of blood and
feces.
Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of
Andosan the effect of this therapy on:
- general blood samples (leucocytes, CRP, liver and renal function tests), including
erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
- level of blood cytokines and analytes
(IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/
17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB,
RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in
patients
- genetic expression in blood leukocytes (microarray) -number of swollen and tender
joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA
impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue
scale (VAS) for patient's and physician's global assessment of disease activity, life
quality (SF-36 version 2), fatigue score.
Partial aims: To compare prior to (day 0) and after (day 21) daily (30 ml x 2) ingestion of
Andosan the effect of this therapy on:
- general blood samples (leucocytes, CRP, liver and renal function tests), including
erythrocyte sedimentation rate (SR) and pentraxin 3 (PTX3)
- level of blood cytokines and analytes
(IL-1α/-1ra/-2/-4/-5/-6/-7/-8/-9/-10/-12(p70)/-13/-15/
17,G-CSF,GM-CSF,MCP-1,MIP-1ß/-1α,IFNγ,TNFα and basic FGF, eotaxin, PDGF-BB,
RANTES,VEGF;27-plex) -level of inflammatory marker calprotectin in feces and blood in
patients
- genetic expression in blood leukocytes (microarray) -number of swollen and tender
joints, morning stiffness, Disease activity score 28 calculated by ESR (DAS28-ESR), RA
impact of disease score (RAID), Health Assessment Questionnaire (HAQ), visual analogue
scale (VAS) for patient's and physician's global assessment of disease activity, life
quality (SF-36 version 2), fatigue score.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Symptom score
The symptom score will be registered at day 1 prior to the patients are given Andosan for 21 days, and at day 21 after the patients have consumed Andosan daily for 21 days.
The duration of the experiment is 3 weeks (21 days)
No
Egil Johnson, Md, PhD
Principal Investigator
Dep. of gastric- and pediatric surgery, Oslo University Hospital, Ulleval, Kirkeveien 166, 0407 Oslo
Norway: Ethics Committee
2012/1962
NCT01815411
April 2014
September 2015
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