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

NCT ID: NCT01634256

Last Updated: 2012-10-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Hepatic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fermented turmeric

Group Type EXPERIMENTAL

Fermented turmeric

Intervention Type DIETARY_SUPPLEMENT

Fermented turmeric(3.0g/day)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo(3.0g/day)

Interventions

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Placebo

Placebo(3.0g/day)

Intervention Type DIETARY_SUPPLEMENT

Fermented turmeric

Fermented turmeric(3.0g/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Wook Kim, MS

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 23497020 (View on PubMed)

Other Identifiers

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INs-LF-CURCUMA

Identifier Type: -

Identifier Source: org_study_id