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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
  Purpose

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.


Condition Intervention
Hepatitis C
Nutritional Status
Hepatitis, Viral, Human
 Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: March 2003
Study Completion Date: September 2004
Arms Assigned Interventions
No Intervention: G1 Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Agaricus blazei powder, 10 grams/day, for 5 months
Experimental: G2 Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Agaricus blazei powder, 10 grams/day, for 5 months

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.

  Eligibility

Ages Eligible for Study:   24 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564811

Locations
Brazil
Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP
Botucatu, Sao Paulo, Brazil, 18618-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Study Chair: Caramori A Carlos, MD, PhD Botucatu Medicine School - Sao Paulo State University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00564811     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-03
Study First Received: November 27, 2007
Last Updated: November 27, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Agaricus blazei (Murrill) ss. Heinemann,
Hepatitis C
Nutritional status
Liver Function Tests
Antiviral Agents

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Hepatitis C
Liver Diseases
Digestive System Diseases
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 17, 2012