Acupuncture as an Adjunctive Treatment for Hepatitis C Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin). Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline characteristics(17,18,19). Patients will be randomized into intervention and control groups, 30 patients each.In the Intervention group each patient will receive an acupuncture treatment once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol will be individualized for each patient according to TCM diagnosis. This treatment protocol is acceptable and has been published(20,21,22).In the control group patients will receive standard treatment alone, with no other intervention. Data collection: after 12 weeks patients will again undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) in order to detect changes from baseline and group differences. Inclusion criteria: adult patients with a confirmed HCV infection Exclusion criteria: Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1 year Study Location: "Ziv" medical center, division of liver disease, Israel
Trial Health
Trial Health Score
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Started Jan 2013
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 17, 2012
December 1, 2012
1 year
November 26, 2012
December 12, 2012
Conditions
Keywords
Study Arms (2)
Intervention group - acupuncture treatment
EXPERIMENTALControl group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Adult patients with a confirmed HCV infection
You may not qualify if:
- Under 18 years
- Can not receive standard Peg interferon+ ribavirin treatment for any reason
- Psychiatric diagnosis
- Anaemia of hematologic origin
- Diabetic patient with uncontrolled diabetes
- Congestive heart failure, arrhythmia
- Hepatocellular carcinoma
- HIV infection
- Hepatitis B infection
- Auto immune liver disease or alcoholic liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assy Nimerlead
Study Sites (1)
Ziv Medical Center
Safed, 13100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Assy Nimer
Study Record Dates
First Submitted
November 26, 2012
First Posted
December 17, 2012
Study Start
January 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 17, 2012
Record last verified: 2012-12