Back to resultsEffect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
Primary Purpose
Hepatitis C, Nutritional Status, Hepatitis, Viral, Human
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Agaricus blazei (Murrill) ss. Heinemann,, Hepatitis C, Nutritional status, Liver Function Tests, Antiviral Agents
Eligibility 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.
Sites / Locations
- Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
G1
G2
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00564811
First Posted
November 27, 2007
Last Updated
May 27, 2015
Sponsor
UPECLIN HC FM Botucatu Unesp
1. Study Identification
Unique Protocol Identification Number
NCT00564811
Brief Title
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
Official Title
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Nutritional Status, Hepatitis, Viral, Human
Keywords
Agaricus blazei (Murrill) ss. Heinemann,, Hepatitis C, Nutritional status, Liver Function Tests, Antiviral Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G1
Arm Type
No Intervention
Arm Title
G2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Intervention Description
Agaricus blazei powder, 10 grams/day, for 5 months
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caramori A Carlos, MD, PhD
Organizational Affiliation
Botucatu Medicine School - Sao Paulo State University
Official's Role
Study Chair
Facility Information:
Facility Name
Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
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