Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Hydrolyzed oyster extract
A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
Hydrolyzed oyster extract
1 tablet of oyster extract t.i.d. for 8 weeks
Placebo
A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin
Placebo
1 tablet of maltodextrin t.i.d. for 8 weeks
Interventions
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Hydrolyzed oyster extract
1 tablet of oyster extract t.i.d. for 8 weeks
Placebo
1 tablet of maltodextrin t.i.d. for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* AST, ALT, and GGT levels above the upper limit of the normal but less than 3 times the upper limit of the normal
* Participants with normal physical activity who sign an informed consent form
* Fatty liver detected by ultrasound
Exclusion Criteria
* Uncontrolled diabetes mellitus
* Active viral hepatitis and any liver diseases that can affect trial outcomes (positive for HBs Ag or HCV Ab)
* Liver cirrhosis of Child-Pugh class B or C
* Chemotherapy or radiation therapy for cancer within 6 months
* Cholelithiasis
* Systemic medications that can affect liver function such as INH, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen and diclofenac within 4 weeks
* Medication of cholagogues, cholelitholytics \& hepatic protectors, antidotes, detoxifying agents, and drug abuse (drugs used in substance dependence) within 4 weeks
* Alcoholism or excessive alcohol intake of more than 168 g/week in men and 112 g/week in women
* Kidney diseases or serum creatinine level above 2.0 mg/dL
* Uncontrolled hypertension or angina pectoris or myocardiac infarction
* History of bowel resection (not including surgery on simple appendicitis)
* Medication of antipsychotic drugs
* Herbal medication within 2 months
* Pregnancy or breastfeeding
* Participation of other clinical trial(s) within 1 months from screening day
* Uncooperativeness
* Intake of dietary supplements within 4 weeks
19 Years
ALL
Yes
Sponsors
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Korean Medicine Hospital of Pusan National University
OTHER
Responsible Party
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Principal Investigators
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Jun-Yong Choi
Role: PRINCIPAL_INVESTIGATOR
Korean Medicine Hospital, Pusan National University
Central Contacts
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Other Identifiers
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2016_11_Crassostrea gigas
Identifier Type: -
Identifier Source: org_study_id