Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)

Not Applicable

Completed

• Conditions: Nutritional Status; Hepatitis, Viral, Human; Hepatitis C
• Interventions: Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)

• Registration Number: NCT00564811
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief Summary

The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.

Detailed Description

Ten patients were studied (5 - GI - not taking A. blazei - and 5 - G2 - taking A. blazei), from both sexes, with positive Anti-VHC and a healthy nutritional state, admitted into in the viral hepatitis ward. Diagnosis and treatment for hepatitis C concurred with the regulations of the Ministry of Health and nutritional evaluation was performed in 3 moments according to anthropometrical, bioimpedance, biochemical and dietary standards, with duration of 6 months. The consumption of A. blazei (10g/day) in dehydrated powder was concomitant with antiviral therapy (conventional or pegylated interferon associated with ribavirin) with duration of 5 months.

Study Timeline

• Study Start: 2003-03
• Study Completion: 2004-09
• Study First Submitted: 2007-11-27
• Study First Submitted QC: 2007-11-27
• Study First Posted: 2007-11-28
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• To have been informed and signed adequately the free and clarified assent
• Initiating the anti-viral treatment (interferon or pegylated interferon associate the ribavirin)
• Age: 24-70 years
• Gender :both the gender
• Race : all races
• To present serology positive to the anti-VHC ELISA
• To present genotype type 1,2,or 3
• Body mass index- >18,5 e < 35kg /m2
• Conditions full to the ORAL ingestion

Exclusion Criteria

• Don't agree to the project or don't have signed the term of clarified free assent
• Restriction for oral ingestion
• The existence of surface of antigen of the hepatitis B virus(Ag HBs)
• The existence of antibody for the human immunodeficiency virus
• To be enclosed in another project of research or form of treatment
• Pregnant women
• Suckles
• Cirrhosis
• Patients with hepatitis auto-imune.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G2	Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)	-

Primary Outcome Measures

Name	Time	Method
Measure: influence of Agaricus blazei (Murrill) ss. Heinemann on the evolution of nutritional state and liver function in hepatitis C patients. Time Frame: six months	Time Frame: six months

Trial Locations

Locations (1)

Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP; 🇧🇷 Botucatu, Sao Paulo, Brazil