None listed
Conditions
Interventions
Drug : Patients assigned to Hanlim high-dose group take two tablets of Hanslim(Hanslim 865mg/tab with Hanslim dried extracts 480mg) two times per day for 12 weeks.
Patients assigned to Hanlim low-dose
Sponsors
Hanpoong Pharm & Foods
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 19 to 65 years 2. Subjects who meet one of the following criteria 1) Obesity subjects with BMI(body mass index) more than 30kg/? 2) Obesity subjects with BMI(body mass index) 27~29.9kg/? who has one or more risk factors such as hypertension, diabetes, hyperlipidemia. 3. Subjects who agreed low-calorie diet during clinical trial period 4. Subjects who singed a consent from after providing explanation about characteristics of this clinical trial
Exclusion criteria
Exclusion criteria: 1. Endocrine disease which could affect weight such as hypothyroidism, Cushing's syndrome and so on. 2. Subjects with heart diseases (heart failure, angina pectoris, myocardial infarction), respiratory diseases (asthma, obstructive pulmonary disease), stroke or ischemic heart failure who were not able to participate in this study 3. Subjects with malignant tumors within the last 5 years 4. Subjects who has narrow angle glaucoma 5. Cholelithiasis 6. Resistant hypertension 7. Severe renal function impairment (serum creatine > 2.0 mg/dL) 8. Severe liver function impairment (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase = 2.5 times of upper limit of normal range) 9. Uncontrolled diabete with HbA1c more than 8% 10. Patients with a neurological or psychologically significant history of the disease or who are currently suffering from the disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, hyperphagia etc.) 11. Subjects who have taken oral steroids with high doses (more than prednisolon 30mg per day or equivalent doses) or long times (more than 8 weeks) 12. Subjects who have taken ß-blocker or diuretic as drugs for hypertension , anorexiants, relievers(without preion), thyroid hormone, amphetamine, cyproheptadine, phenothiazine, contraceptive or female hormones within the last 3 months that can affect on weight. 13. Subjects who have taken other forbidden treatments(insulin, antidepressants, anti serotonin reuptake inhibitor, barbiturate, antipsychotics, drugs concerned with misuse) 14. Subjects who underwent anatomical change such as incision which makes it difficult to conduct physical measurements 15. Subjects who underwent surgeries for weight 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, intrauterine device, spermicide, condom, celibacy. 17. Subjects who have lost more than 10% of body weight within the last 6 months 18. Cessation of smoking within the last 3 months or an irregular smoking habit 19. Subjects who are participating in other intervention studies or who have taken other investigational drugs within the last one month 20. Subjects who are judged to be unable to comply the study according to the findings of the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects who lost weight by more than 5% compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat percentage;Fat mass;Waist circumference;Body mass index;Waist-hip ratio ;Serum lipid;Blood glucose;C-reactive protein;Laboratory experiment;Vital sign;Pregnancy test;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSeunghoon Lee
Kyung Hee University Oriental Medical Center
Outcome results
None listed