A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of opuntia ficus-indica extract on improving liver funtion.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000867

Enrollment

Registered

2013-10-01

Start date

2013-10-07

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomized to receive Opuntia ficus-indica extract 1440mg or plecebo. Subjects will take orally self-adminster Opuntia ficus-indica extract 1440mg or plecabo qd,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Male and Female subject between 20-75years of age inclusive 2)Subject who average Alcohol intake habits male 14unit and female 7unit = 1 week duaring the last 1 month in alcohol intake survey 3) Subject who AST(GOT) or ALT(GPT) of ?-GTP >the upper limit of normal within the normal range. 4) Evidence of a personally signed and dated informed consent document indicating that the subject has heen informed of all pertinent aspects of the trial.

Exclusion criteria

Exclusion criteria: 1)Subjects who are hospitalization, medication treatment and rehabilitation treatment cause a using alchol using·induced disorders, heart disease, centrol nervous system disorder 2)Subject who liver cirrhosis or liver cancer in abdominal sono 3)Serum ALP or LDH = 3 times the upper limit of normal or Platlet = 100,000/ml or AFP >20 ng/mL 4)Diagnosis viral hepatitis 5)Subject who HBs Ag or HCV Ab positive in screening test 6)Subject who Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl 7)Subject who PT = 15sec or aPTT = 45sec 8)Serum creatine = 2 times the upper limit of normal 9)Subject who TSH = 0.1uU/ml and = 10uU/ml 10)Subject who taking a drug influence of liver function( INH,valproic acid,tetracycline, allopurinol, etc, the potential to cause liver toxicy.) 11)Subject who taking a adrenal cortical hormone or sex hormone within the 4 weeks prior to screening. 12) Subject for uncontrolled hypertension disease( more than 160/100mmHg, measure after 10 minutes steady) 13) Subject for uncontrolled diabetes mellitus disease.( fasting plasma glucose more than 180mg/dl or if start taking a new drug because diabetes mellitus disease within 3 months 14) if you taking a new drug of anti-lipid linewithin 3 months.( if you are given before 3 months is involved.) 15)Subject who complain gastrointestinal symptoms such as heartburn, dyspepsia 16)Woman who are pregnant of lactating or planning to pregnant 17)Subjects who have a plan to participate in other clinical trial. 18)Participation in any clinical trail within the 1 month prior to screening. 19)Subjects which in the opinion investigator could affect preclude evluation of response.

Design outcomes

Primary

Measure	Time frame
Change of serum AST	—

Secondary

Measure	Time frame
Changes of ALT, ?-GTP;Change of AST/ALT ratio;Change of Multidimensional Fatigue Scale(MFS);Changes of serum lipid profile(Total cholesterol, Triglyceride, HDL cholesterol, LDL cholesterol)	—

Countries

Korea, Republic of

Contacts

Public ContactHAE LIM

Inje University Seoul Paik Hospital

Outcome results