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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented turmeric | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo(3.0g/day) |
| |
| Fermented turmeric |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Wook Kim, MS | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497020 | Derived | Kim SW, Ha KC, Choi EK, Jung SY, Kim MG, Kwon DY, Yang HJ, Kim MJ, Kang HJ, Back HI, Kim SY, Park SH, Baek HY, Kim YJ, Lee JY, Chae SW. The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study. BMC Complement Altern Med. 2013 Mar 8;13:58. doi: 10.1186/1472-6882-13-58. |
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The criteria were an age from 19 to 70 years, ALT levels ≥ 40IU/L subjects.
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo | Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Fermented turmeric. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fermented Curcuma | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in ALT(Alanine Transaminase) | ALT was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | IU/L | 12 weeks |
|
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fermented Curcuma | Oral intake fermented curcuma (3.0g/day) for 12weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sang-Wook Kim, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | clickm@jbnu.ac.kr |
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| Dietary Supplement |
Fermented turmeric(3.0g/day) |
|
| 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 |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Changes in AST(Aspartate Transaminase) | AST was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | IU/L | 12 weeks |
|
|
|
| Secondary | Changes in ALP(Alkaline Phosphatase) | ALP was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | IU/L | 12 weeks |
|
|
|
| Secondary | Changes in γ-GT(Gamma-Glutamyl Transferase) | γ-GT was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | IU/L | 12 weeks |
|
|
|
| Secondary | Changes in Serum Bilirubin | serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | Oral intake placebo(3.0g/day) for 12weeks | 0 | 30 | 0 | 30 |
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