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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564811
• Other study ID #: upeclin/HC/FMB-Unesp-03
• Status: Completed
• Phase: N/A
• First received: November 27, 2007
• Last updated: May 27, 2015
• Start date: March 2003
• Est. completion date: September 2004

Study information

• Verified date: May 2015
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis, Viral, Human
• Nutritional Status

Intervention

Dietary Supplement:
• Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Agaricus blazei powder, 10 grams/day, for 5 months

Locations

Country	Name	City	State
Brazil	Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP	Botucatu	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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