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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01634256

Enrollment

Registered

2012-07-06

Start date

2011-02-28

Completion date

2012-01-31

Last updated

2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Hepatic Injury

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Placebo(3.0g/day)

DIETARY_SUPPLEMENTFermented turmeric

Fermented turmeric(3.0g/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Countries

South Korea

Participant flow

Recruitment details

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-assignment details

The criteria were an age from 19 to 70 years, ALT levels ≥ 40IU/L subjects.

Participants by arm

Arm	Count
Fermented Curcuma	30
Placebo	30
Total	60

Baseline characteristics

Characteristic	Placebo	Fermented Curcuma	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	30 Participants	30 Participants	60 Participants
Age Continuous	36.17 years STANDARD_DEVIATION 7.42	39.03 years STANDARD_DEVIATION 8.53	37.60 years STANDARD_DEVIATION 8.06
Region of Enrollment Korea, Republic of	30 participants	30 participants	60 participants
Sex: Female, Male Female	2 Participants	2 Participants	4 Participants
Sex: Female, Male Male	28 Participants	28 Participants	56 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

Primary