Hepatitis CNCT00564811
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
A study testing Agaricus blazei (Murrill) ss. Heinemann (sun mushroom) in people with Hepatitis C and Nutritional Status, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 24 to 70 years
- Conditions the study is for
- Hepatitis C, Nutritional Status, Hepatitis, Viral, Human
- What is being tested?
- Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2003to Sep 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- To present genotype type 1,2,or 3
- Body mass index- >18,5 e < 35kg /m2
- Conditions full to the ORAL ingestion
Who cannot join
- 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
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- Suckles
- Cirrhosis
- Patients with hepatitis auto-imune.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP
Botucatu, São Paulo, 18618-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C, Nutritional Status, Hepatitis, Viral, Human
- Being tested
- Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
- Keywords
- Agaricus blazei (Murrill) ss. Heinemann,, Hepatitis C, Nutritional status, Liver Function Tests, Antiviral Agents
- Medical subject headings
- Hepatitis C, Hepatitis, Viral, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)Dietary supplement
Agaricus blazei powder, 10 grams/day, for 5 months
| Study group | Role | What they receive |
|---|---|---|
| G1 | No intervention | Not described |
| G2 | Experimental | Not described Receives: Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startMar 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Caramori A Carlos, MD, PhD, Study chair, Botucatu Medicine School - Sao Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564811
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-03
- Status last verified
- May 2015
- First submitted
- 27 Nov 2007
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.
- ClinicalTrials.gov ID
- NCT00564811
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-03
- Conditions
- Hepatitis C, Nutritional Status, Hepatitis, Viral, Human
- Keywords
- Agaricus blazei (Murrill) ss. Heinemann,, Hepatitis C, Nutritional status, Liver Function Tests, Antiviral Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 28 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 | No intervention | – |
| G2 | Experimental | Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom) |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)Agaricus blazei powder, 10 grams/day, for 5 months | Dietary supplement | G2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caramori A Carlos, MD, PhD study chair
Botucatu Medicine School - Sao Paulo State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agaricus blazei (Murrill) ss. Heinemann (sun mushroom) in people with Hepatitis C and Nutritional Status, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.