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.
- Conditions
- Not Applicable
- Registration Number
- KCT0000867
- Lead Sponsor
- Elcomscience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of serum AST
- Secondary Outcome Measures
Name Time Method 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)