Andosan-RAEffect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)
Mushroom extract
Artritis+8
+ Enfermedades Autoinmunes
+ Enfermedades del Tejido Conectivo
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de mayo de 2016
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 10 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 19 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Sin IntervenciónObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, NorwayAbrir Lillehammer Hospital for Rheumatic Diseases en Google Maps