Trial Outcomes & Findings for A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury (NCT NCT01634256)

NCT ID: NCT01634256

Last Updated: 2012-10-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-10-04

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Fermented Turmeric Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks Fermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours.	Placebo Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Fermented turmeric.
Overall Study STARTED	30	30
Overall Study COMPLETED	26	22
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fermented Curcuma n=30 Participants	Placebo n=30 Participants	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	39.03 years STANDARD_DEVIATION 8.53 • n=5 Participants	36.17 years STANDARD_DEVIATION 7.42 • n=7 Participants	37.60 years STANDARD_DEVIATION 8.06 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Korea, Republic of	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

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

Outcome measures

Outcome measures
Measure	Fermented Turmeric n=26 Participants Oral intake Fermented turmeric (3.0g/day) for 12weeks.	Placebo n=22 Participants Oral intake placebo(3.0g/day) for 12weeks
Changes in ALT(Alanine Transaminase) Pre	61.08 IU/L Standard Deviation 25.10	55.68 IU/L Standard Deviation 15.09
Changes in ALT(Alanine Transaminase) Post	44.92 IU/L Standard Deviation 15.47	53.82 IU/L Standard Deviation 26.27

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

AST was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Fermented Turmeric n=26 Participants Oral intake Fermented turmeric (3.0g/day) for 12weeks.	Placebo n=22 Participants Oral intake placebo(3.0g/day) for 12weeks
Changes in AST(Aspartate Transaminase) Pre	36.27 IU/L Standard Deviation 13.80	35.59 IU/L Standard Deviation 8.82
Changes in AST(Aspartate Transaminase) Post	27.96 IU/L Standard Deviation 7.96	34.77 IU/L Standard Deviation 10.87

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

ALP was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Fermented Turmeric n=26 Participants Oral intake Fermented turmeric (3.0g/day) for 12weeks.	Placebo n=22 Participants Oral intake placebo(3.0g/day) for 12weeks
Changes in ALP(Alkaline Phosphatase) Pre	85.04 IU/L Standard Deviation 19.33	71.73 IU/L Standard Deviation 13.47
Changes in ALP(Alkaline Phosphatase) Post	80.04 IU/L Standard Deviation 21.98	68.95 IU/L Standard Deviation 13.21

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

γ-GT was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Fermented Turmeric n=26 Participants Oral intake Fermented turmeric (3.0g/day) for 12weeks.	Placebo n=22 Participants Oral intake placebo(3.0g/day) for 12weeks
Changes in γ-GT(Gamma-Glutamyl Transferase) Post	66.96 IU/L Standard Deviation 45.63	100.77 IU/L Standard Deviation 68.36
Changes in γ-GT(Gamma-Glutamyl Transferase) Pre	86.31 IU/L Standard Deviation 71.49	104.2 IU/L Standard Deviation 69.00

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Fermented Turmeric n=26 Participants Oral intake Fermented turmeric (3.0g/day) for 12weeks.	Placebo n=22 Participants Oral intake placebo(3.0g/day) for 12weeks
Changes in Serum Bilirubin Pre	0.98 mg/dL Standard Deviation 0.46	0.89 mg/dL Standard Deviation 0.28
Changes in Serum Bilirubin Post	0.88 mg/dL Standard Deviation 0.38	0.84 mg/dL Standard Deviation 0.26

Adverse Events

Fermented Curcuma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sang-Wook Kim, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place