- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00564811
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
May 27, 2015 updated by: UPECLIN HC FM Botucatu Unesp
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
Botucatu, Sao Paulo, Brazil, 18618-000
- Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G2
|
Agaricus blazei powder, 10 grams/day, for 5 months
|
No Intervention: G1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Time Frame: six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Caramori A Carlos, MD, PhD, Botucatu Medicine School - Sao Paulo State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
November 27, 2007
First Submitted That Met QC Criteria
November 27, 2007
First Posted (Estimate)
November 28, 2007
Study Record Updates
Last Update Posted (Estimate)
May 29, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- upeclin/HC/FMB-Unesp-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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