A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury

September 4, 2012 updated by: Soo-Wan Chae, Chonbuk National University Hospital
The investigators performed a double-blind parallel study in a group of showing mild hepatic injury subjects who were given Fermented turmeric over a period of 12 weeks. The investigators measured liver function parameters , including ALT(Alanine Transaminase), AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and serum bilirubin, and monitored their blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

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

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females 19-70 years old
  • Mild hepatic injury as indicated by ALT(Alanine Transaminase) level ≥ 40
  • Able to give informed consent

Exclusion Criteria:

  • Allergy or hypersensitivity to any of the ingredients in the test products
  • History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • Carriers of viral hepatitis (type B and C)
  • History of underlying Esophageal varices, hepatic encephalopathy, ascites(past 12 months)
  • Participation in other clinical trials within the past 2 months
  • Patients with acute hepatitis (type B and C)
  • History of underlying cirrhosis and liver cancer
  • History of underlying biliary diseases such as jaundice or gallstones
  • History of underlying kidney disease such as Chronic renal failure or nephrotic syndrome
  • Pregnant, planning to become pregnant, or breast-feeding
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo(3.0g/day)
Experimental: Fermented turmeric
Dietary supplement: Fermented turmeric
Fermented turmeric(3.0g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ALT(Alanine Transaminase)
Time Frame: 12 weeks
ALT was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in AST(Aspartate Transaminase)
Time Frame: 12 weeks
AST was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in ALP(Alkaline Phosphatase)
Time Frame: 12 weeks
ALP was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in γ-GT(Gamma-Glutamyl Transferase)
Time Frame: 12 weeks
γ-GT was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Serum Bilirubin
Time Frame: 12 weeks
serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Investigators

  • Principal Investigator: Sang-Wook Kim, MS, Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INs-LF-CURCUMA

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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