Effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on progression and outcomes of Hepatitis C.
- Conditions
- Hepatitis CInfection - Other infectious diseasesAlternative and Complementary Medicine - Herbal remediesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12615000645550
- Lead Sponsor
- ycotec Ltd, Cambridge, UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1.Consented males or females 18-65 years of age and testing positive for any HCV genotype on the standard interferon therapy.
2.Newly diagnosed cases of Hepatitis C as well as patients with chronic Hepatitis C patients positive in quantitative and qualitative PCR with concomitant increase of liver-specific enzymes in serum (>2 folds over control level).
3.Stable clinical conditions not requiring emergency care
1.Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy.
2.Co-infections with Hepatitis B virus and Human immunodeficiency virus (HIV).
3.Received any investigational drug agent(s) within 28-days of entry into study.
4.Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia).
5.Subjects with ECG showing clinically significant abnormalities.
6.Need for frequent blood transfusions.
7.Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.
8.Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).
9.Any medical condition, other than HCV, requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immune-regulatory medications.
10.Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months.
11.Any cancer requiring systemic chemotherapy.
12.Any other condition that, in the opinion of the principal investigators or treating physicians, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the expanded access protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective of this clinical trial is to verify an effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on HCV viral load as determined by quantitative polymerase chain reaction protocol.<br><br>[End of 6th month of interventional period.];Another study outcome is to verify an effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on <br>liver functions as assessed by biochemical measurements of liver-specific enzymes (alanin- and aspartat-aminotransferases, gamma-glutamyltranspeptidase and others}.[End of the 6th month of interventional period]
- Secondary Outcome Measures
Name Time Method Investigation of the effect of lycosomal formulation of lycopene and resveratrol chaperoned with phosphatidylcholine on HCV viral load in patients with different HCV genotypes as determined by quantitative polymerase chain reaction.<br><br><br>[end of 4th and 6th months of interventional time period.];Investigation of the effect of lycosomal formulation of lycopene and resveratrol chaperoned with phosphatidylcholine on inflammatory status as determined by measurements of C-reactive protein, Interleukin-6 and -10 levels using analytic chemistry methods. [end of 4th and 6th months of interventional time period.];Investigation of the effect of lycosomal formulation of lycopene and resveratrol chaperoned with phosphatidylcholine on immunological profile of patients with Hepatitis C by measurement of populations of B- and T-lymphocytes using flow cytometry.[end of 4th and 6th months of interventional time period.]