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

Study Overview
=================
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.

Conditions
-----------------
Mild Hepatic Injury

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Fermented turmeric


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented turmeric<br> | Dietary Supplement: Fermented turmeric<br>* Fermented turmeric(3.0g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo(3.0g/day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ALT(Alanine Transaminase) | ALT was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

Secondary Outcome Measures

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