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

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ClinicalTrials.gov Identifier: NCT01634256
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Hepatic Injury Dietary Supplement: Placebo Dietary Supplement: Fermented turmeric Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : February 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fermented turmeric Dietary Supplement: Fermented turmeric
Fermented turmeric(3.0g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo(3.0g/day)


Outcome Measures
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Primary Outcome Measures :
  1. Changes in ALT(Alanine Transaminase) [ Time Frame: 12 weeks ]
    ALT was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures :
  1. Changes in AST(Aspartate Transaminase) [ Time Frame: 12 weeks ]
    AST was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in ALP(Alkaline Phosphatase) [ Time Frame: 12 weeks ]
    ALP was measured in study visit 1(0 week) and visit 3(12 week).

  3. 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).

  4. Changes in Serum Bilirubin [ Time Frame: 12 weeks ]
    serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634256


Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
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Principal Investigator: Sang-Wook Kim, MS Chonbuk National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01634256    
Other Study ID Numbers: INs-LF-CURCUMA
First Posted: July 6, 2012    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Wounds and Injuries