A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Citrus aurantium extract on improving liver functio

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0001869
• Lead Sponsor: utraPharmTech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Male and female subject aged between 20 years and 75 years
2) Subject with abnormal serum AST(GOT) or ALT(GPT) level and less than 3 times the upper limit of normal.
3) Subject who agrees to participate in the study and signs the informed consent form

Exclusion Criteria

1) Subject with a history of hospitalization, a medication or rehabilitation therapy to treat alcohol use disorders, alcohol-induced disorders, cardiac disorders and central nervous system diseases
2) Subject with cholelithiasis or gallstone
3) Subject with liver cirrhosis or hepatoma on ultrasonography
4) Subject with Alkaline Phosphatase(ALP) = 3 times the upper limit of normal or Platelet < 105/ml or AFP > 20 ng/mL
5) Subject diagnosed with viral hepatitis
6) Subject with HBs Ag or HCV Ab positive in screening test
7) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl
8) Subject with Creatinine = 2 times the upper limit of normal
9) Subject taking a drug influence of liver function (INH, valproic acid,tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac etc, the potential to cause liver toxicy) within 4 weeks
10) Subject taking cholagogues, cholelitholytics, hepatic Protectors, antidotes, detoxifying agents and drugs used in substance dependence within 4 weeks
11) Subject taking any Chinese herbs or health functional foods related to liver function within 2 weeks
12) Subject taking an adrenal cortical hormone or sex hormone within 4 weeks
13) Subject with uncontrolled hypertension (over 160/100mmHg, when measuring after 10 minutes steady)
14) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose or start taking other diabetes medications within 3 months)
15) Subject taking a new antihyperlipidemic drug within 3 months. (If a subject is taking an antihyperlipidemic drug before 3 months, the subject can participate in this study.)
16) Subject with complaint of severe gastrointestinal symptoms such as heartburn, dyspepsia
17) Subject who is pregnant or planning to pregnant within 3 months
18) Subject planning to participate in the other clinical study
19) Subject participated in any clinical trial within 1 month
20) Inappropriate subject decided by the investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of serum Aspartate Aminotransferase(AST) level

Secondary Outcome Measures

Name	Time	Method
Change of serum Alanine transaminase(ALT) and Gamma-glutamyl transpeptidase(r-GTP) levels;Change of AST/ALT ratio;Change of Multidimensional Fatigue Scale (MFS) ;Change of blood lipid profile(Total-cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol) ;Measurement of liver fat using CT scan: liver attenuation HU(Hounsfield Unit) and spleen attenuation HU, difference between liver HU and spleen HU, ratio of liver HU to spleen HU;Change of antioxidative markers (Malondialdehyde(MDA), Total Antioxidant Status(TAS))