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

Phase 2

Completed

• Conditions: Mild Hepatic Injury
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Fermented turmeric

• Registration Number: NCT01634256
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Results First Submitted: 2012-07-11
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-04
• Last Update Submitted: 2012-09-04
• Results First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Fermented turmeric	Fermented turmeric	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of