A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002208
- Lead Sponsor
- Gil Korean Medicine Hospital, Gachon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 120
Female aged 18 to 65 years
- Subject must included at least one or more of the following symptoms below
? Body Mass Index of 30 kg/? or more;
? Body Mass Index between 25 and 29.9kg/? with hypertension, taking medication or systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg at the screening visit
? Body Mass Index between 25 and 29.9kg/? with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
? Body Mass Index between 25 and 29.9kg/? with hyperlipidemia, taking medication or total cholesterol = 200mg/dL or Triglyceride = 150mg/dL at screening visit
- Agreed to low-calorie diet during the trial
- Written informed consent of the trial
- Endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
- Heart disease (heart failure, angina pectoris, myocardial infarction)
- Cholelithiasis
- Severe renal disability (serum creatinine concentration > 2.0 mg/dL)
- Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
- History of narrow angle glaucoma
- History of stroke or temporary ischemic cardioplegia
- History of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
- Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion)
- Use of central nerve system(CNS) stimulant medication for weight loss
- Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
- history of weight loss surgery, such as bariatric surgery, etc.
- Subjects who are judged to be inappropriate for the clinical study by the researchers
- Women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, intrauterine device, spermicide, condom, abstinence, etc.)
- Use of other investigational product within last 1 month
- 10 percent reduction in body weight over 6 months
- Decided to quit smoking over the last 3 months or have irregular smoking habits
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes from baseline in body weight
- Secondary Outcome Measures
Name Time Method Changes from baseline in body fat percentage and fat mass;Changes from baseline in Waist circumference, Waist/hip ratio, Body mass index;Changes from baseline in Lipid profile and C-reactive protein, blood glucose, blood pressure;Changes from baseline in abdominal visceral fat area;Korean Obesity-related Quality of Life scale;Korean version of Eating Attitudes Test-26;Lab test