Efficacy and Safety of Hanslim for Obesity

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 165

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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of subjects who lost weight by more than 5% compared to baseline

Secondary Outcome Measures

Name	Time	Method
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