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Completed

NCT Number: NCT01634256

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

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.

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Key information

Conditions

Mild Hepatic Injury

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo(3.0g/day)

Fermented turmeric

Dietary Supplement

Fermented turmeric(3.0g/day)

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jul 6, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.