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Completed

NCT Number: NCT00564811

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

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.

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Key information

Age range

24 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP

Botucatu, São Paulo, 18618-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)

Dietary Supplement

Agaricus blazei powder, 10 grams/day, for 5 months

Primary outcomes

  1. 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: Time Frame: six months

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Registry information

Official study title

Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.

Important dates

Study start
2003
Study completion
2004
First posted
Nov 28, 2007
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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