Phase 3
N=60
A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury
Mild Hepatic Injury
Bottom Line
View on ClinicalTrials.gov: NCT01634256 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Changes in ALT(Alanine Transaminase) — 61.08; 55.68; 44.92; 53.82 IU/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Dietary_supplement); Fermented turmeric (Dietary_supplement)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Chonbuk National University Hospital
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in ALT(Alanine Transaminase) |
61.08; 55.68; 44.92; 53.82 | — |
| SECONDARY Changes in AST(Aspartate Transaminase) |
36.27; 35.59; 27.96; 34.77 | — |
| SECONDARY Changes in ALP(Alkaline Phosphatase) |
85.04; 71.73; 80.04; 68.95 | — |
| SECONDARY Changes in γ-GT(Gamma-Glutamyl Transferase) |
86.31; 104.2; 66.96; 100.77 | — |
| SECONDARY Changes in Serum Bilirubin |
0.98; 0.89; 0.88; 0.84 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01634256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.