None listed
Conditions
Interventions
Dietary Supplement : administration of either Schizandra chinensis extracts or placebo extracts three times a week 30 minutes after meal, for 12 weeks.
Sponsors
Dongguk University Ilsan Oriental Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: pre-menopausal female patients of BMI>25kg/m2, aged between 19 to 50.
Exclusion criteria
Exclusion criteria: 1)women with any condition that can affect weight gain such as hypothyroidism, cushing syndrome 2)heart disease(heart failure, angina pectoris, myocardial infarction) 3)cancer or lung disease 4)liver dysfunction(ALT, AST = 2.5 fold upper limit of normal) 5)women who are diagnosed with cholelithiasis 6)severe renal dysfunction (Cr >2.0mg/dl) 7)Narrow angle glaucoma 8)neuropsychiatric diseases(schizophrenia, epilepsy, alcoholism, drug addiction, anorexia nervosa, hyperphagia) 9)past history of stroke, transient ischemic heart disease 10)eating disorder such as anorexia nervosa and bulimia nervosa 11)women who have taken anorexiants, relievers(without prescription), oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or any other medication within 3 months that can affect absorption, metabolism, excretion which can affect on weight. 12)who are on narcotics and neuropsychological drugs for weight reduction 13)other forbidden treatments(insulin, hypogycemic agents, antidepressants, anti serotonin reuptake inhibitor, sodium pentobarbital, antipsychotics, drugs concerned with misuse) 14)women who underwent anatomical change such as incision which makes it difficult to conduct physical measurements 15)women who underwent surgeries for weiight reduction(gastroplastia) 16)pregnant women, breast feeder, women planning a pregnancy and those who do not agree to use adequate contraception such as oral contraceptives, hormone transplant, IUD, spermicide, condom, celibacy. 17)women who have taken other medications provided by clinical trial within a month 18)women who have lost more than 10% of body weight within 6 months 19)women who are judged to be unacceptable for candidate by person in charge of clinical trial 20)women who have given up on smoking within past 3 months but who have irregular smoking habit 21)women who taken antibiotics or prebiotics within 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight | — |
Secondary
| Measure | Time frame |
|---|---|
| body composition (body fat mass, muscle mass) ;blood lipid profile (triglyceride, total cholesterol, HDL cholesterol) ;waist circumference ;blood pressure ;blood glucose ;insulin level;HOMA IR;change inintestinal microbiota | — |
Countries
Korea, Republic of
Contacts
Public ContactHojun Kim
Dongguk University Ilsan Oriental Hospital
Outcome results
None listed