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Trial record 32 of 582 for:    bilirubin AND liver function

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

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ClinicalTrials.gov Identifier: NCT01634256
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Mild Hepatic Injury
Interventions Dietary Supplement: Placebo
Dietary Supplement: Fermented turmeric
Enrollment 60
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.
Arm/Group Title Fermented Turmeric Placebo
Hide Arm/Group Description

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(3times/day, 6capsules/day, 3g/day) for 12weeks

Placebo : Amount and calorie of placebo are same with Fermented turmeric.

Period Title: Overall Study
Started 30 30
Completed 26 22
Not Completed 4 8
Arm/Group Title Fermented Curcuma Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
39.03  (8.53) 36.17  (7.42) 37.60  (8.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
2
   6.7%
2
   6.7%
4
   6.7%
Male
28
  93.3%
28
  93.3%
56
  93.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Changes in ALT(Alanine Transaminase)
Hide Description ALT was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Fermented Turmeric Placebo
Hide Arm/Group Description:
Oral intake Fermented turmeric (3.0g/day) for 12weeks.
Oral intake placebo(3.0g/day) for 12weeks
Overall Number of Participants Analyzed 26 22
Mean (Standard Deviation)
Unit of Measure: IU/L
Pre 61.08  (25.10) 55.68  (15.09)
Post 44.92  (15.47) 53.82  (26.27)
2.Secondary Outcome
Title Changes in AST(Aspartate Transaminase)
Hide Description AST was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Fermented Turmeric Placebo
Hide Arm/Group Description:
Oral intake Fermented turmeric (3.0g/day) for 12weeks.
Oral intake placebo(3.0g/day) for 12weeks
Overall Number of Participants Analyzed 26 22
Mean (Standard Deviation)
Unit of Measure: IU/L
Pre 36.27  (13.80) 35.59  (8.82)
Post 27.96  (7.96) 34.77  (10.87)
3.Secondary Outcome
Title Changes in ALP(Alkaline Phosphatase)
Hide Description ALP was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Fermented Turmeric Placebo
Hide Arm/Group Description:
Oral intake Fermented turmeric (3.0g/day) for 12weeks.
Oral intake placebo(3.0g/day) for 12weeks
Overall Number of Participants Analyzed 26 22
Mean (Standard Deviation)
Unit of Measure: IU/L
Pre 85.04  (19.33) 71.73  (13.47)
Post 80.04  (21.98) 68.95  (13.21)
4.Secondary Outcome
Title Changes in γ-GT(Gamma-Glutamyl Transferase)
Hide Description γ-GT was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Fermented Turmeric Placebo
Hide Arm/Group Description:
Oral intake Fermented turmeric (3.0g/day) for 12weeks.
Oral intake placebo(3.0g/day) for 12weeks
Overall Number of Participants Analyzed 26 22
Mean (Standard Deviation)
Unit of Measure: IU/L
Pre 86.31  (71.49) 104.2  (69.00)
Post 66.96  (45.63) 100.77  (68.36)
5.Secondary Outcome
Title Changes in Serum Bilirubin
Hide Description serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Fermented Turmeric Placebo
Hide Arm/Group Description:
Oral intake Fermented turmeric (3.0g/day) for 12weeks.
Oral intake placebo(3.0g/day) for 12weeks
Overall Number of Participants Analyzed 26 22
Mean (Standard Deviation)
Unit of Measure: mg/dL
Pre 0.98  (0.46) 0.89  (0.28)
Post 0.88  (0.38) 0.84  (0.26)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or other [non-serious] adverse events were not collected/assessed
 
Arm/Group Title Fermented Curcuma Placebo
Hide Arm/Group Description Oral intake fermented curcuma (3.0g/day) for 12weeks. Oral intake placebo(3.0g/day) for 12weeks
All-Cause Mortality
Fermented Curcuma Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fermented Curcuma Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fermented Curcuma Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sang-Wook Kim, MD
Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Phone: 82-63-276-8284
Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01634256     History of Changes
Other Study ID Numbers: INs-LF-CURCUMA
First Submitted: July 3, 2012
First Posted: July 6, 2012
Results First Submitted: July 11, 2012
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012