A 12 week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Tomato vinegar(TV-01) on reducing body weight and body fat of overweight subjects

OTTE Confectionery0 个研究点目标入组 100 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1)Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
•2) Male and female subjects between 20-65years of age inclusive
•3)BMI of 25.0-29.9kg/m2

•1)The Patients with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator)
•2) The patient who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, Antipsychotics hydragogue, contraceptives, steroid, and female sex hormon) within recent 1 months.
•3) subject for uncontrolled hypertension, diabetes mellitus, thyroid disease (If that patient's clinical status is stable, they can participate in the clinical trial in the sight of investigator).
•4)Serum creatinine = 2 times the upper limit of normal.
•5)Serum AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) = 3 times the upper limit of normal.
•6) Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
•7) Subjects with CNS(central nervous system) disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
•8)Subjects with the musculoskeletal disorders or restricted physical activity.
•9)Allergy or hypersensitivity in the Ecklonia cava
•10) Participation in commercial diet program within the 3 months prior to screening.
•11)Participation in any clinical trail within the 1 month prior to screening or have a plan to participate in other clinical trial.
•12)Woman who are pregnant of lactating or planning to pregnant
•13)Subjects which in the opinion investigator could affect preclude evluation of response

发起方

OTTE Confectionery