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

Primary Purpose

Mild Hepatic Injury

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
Fermented turmeric
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Hepatic Injury

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fermented turmeric

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in ALT(Alanine Transaminase)
ALT was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2012
Last Updated
September 4, 2012
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01634256
Brief Title
A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Hepatic Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fermented turmeric
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo(3.0g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented turmeric
Intervention Description
Fermented turmeric(3.0g/day)
Primary Outcome Measure Information:
Title
Changes in ALT(Alanine Transaminase)
Description
ALT was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in AST(Aspartate Transaminase)
Description
AST was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in ALP(Alkaline Phosphatase)
Description
ALP was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in γ-GT(Gamma-Glutamyl Transferase)
Description
γ-GT was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Serum Bilirubin
Description
serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Wook Kim, MS
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23497020
Citation
Kim SW, Ha KC, Choi EK, Jung SY, Kim MG, Kwon DY, Yang HJ, Kim MJ, Kang HJ, Back HI, Kim SY, Park SH, Baek HY, Kim YJ, Lee JY, Chae SW. The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study. BMC Complement Altern Med. 2013 Mar 8;13:58. doi: 10.1186/1472-6882-13-58.
Results Reference
derived

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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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