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Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)


N/A
19 Years
75 Years
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

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.


Inclusion Criteria:



- Age>18 years

- Able and willing to give written informed consent, and to comply with the
requirements of the study protocol.

- Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid
arthritis.

- Moderate disease activity based on the clinical evaluation including DAS28-ESR (DAS28
3.2-5.1) [11, 12].

- Stable medication by disease modifying drugs (DMARDs) and systemic
glucocorticosteroids for 3 months prior to the inclusion.

Exclusion Criteria:

- Lack of cooperativity.

- Clinically significant chronic infection, including positive serology for hepatitis B
or C, history of positive HIV status.

- Acute significant infection during the last 3 weeks before the inclusion. Surgery
during the last 4 weeks before the inclusion, and during the study period.

- Clinically significant malignancy .

- Drug addiction

- Any inflammatory disease of permanence not related to RA.

- Use of prednisolone >7,5 mg daily for 1 month prior to the inclusion.

- Use of biologic treatment including antibodies to cytokines and their receptors for 6
weeks prior to the inclusion.

- Use of intramuscular, intra-articular or intravenous injections of corticosteroids
during or within 4 weeks prior to inclusion in the trial.

- Vaccination during the trial.

- Pregnancy or breast-feeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Symptom score

Outcome Description:

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.

Outcome Time Frame:

The duration of the experiment is 3 weeks (21 days)

Safety Issue:

No

Principal Investigator

Egil Johnson, Md, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dep. of gastric- and pediatric surgery, Oslo University Hospital, Ulleval, Kirkeveien 166, 0407 Oslo

Authority:

Norway: Ethics Committee

Study ID:

2012/1962

NCT ID:

NCT01815411

Start Date:

April 2014

Completion Date:

September 2015

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid arthritis
  • symptom score
  • fatigue
  • life quality
  • cytokines
  • mRNA expression
  • Quality of Life
  • Signs and Symptoms
  • Indication for Modification of Patient Physical Status
  • Arthritis
  • Arthritis, Rheumatoid

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