KCT0000867尚未招募未知
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.
Elcomscience0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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