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

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00564811
First received: November 27, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 27, 2007
November 27, 2007
March 2003
Not Provided
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Nutritional Status
  • Hepatitis, Viral, Human
Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Agaricus blazei powder, 10 grams/day, for 5 months
  • No Intervention: G1
    Intervention: Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
  • Experimental: G2
    Intervention: Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2004
Not Provided

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.
Both
24 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00564811
upeclin/HC/FMB-Unesp-03
Yes
Not Provided
UPECLIN HC FM Botucatu Unesp
Not Provided
Study Chair: Caramori A Carlos, MD, PhD Botucatu Medicine School - Sao Paulo State University
UPECLIN HC FM Botucatu Unesp
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP