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

NCT ID: NCT00564811

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C Nutritional Status Hepatitis, Viral, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G1

Group Type NO_INTERVENTION

No interventions assigned to this group

G2

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

24 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Principal Investigators

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Caramori A Carlos, MD, PhD

Role: STUDY_CHAIR

Botucatu Medicine School - Sao Paulo State University

Locations

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

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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upeclin/HC/FMB-Unesp-03

Identifier Type: -

Identifier Source: org_study_id

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