ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 3104 for:    "Hepatitis, Viral, Human"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00564811
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : May 29, 2015
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Nutritional Status Hepatitis, Viral, Human Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2003
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: G1
Experimental: G2 Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Agaricus blazei powder, 10 grams/day, for 5 months



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   24 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00564811     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-03
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

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, Viral, Human
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections