exploring the efficacy and safety of herbal medicine on korean obese women with or without metabolic syndrome risk factors - a study protocol for a double-blind, randomised, multi-center, placebo-controlled clinical trial

Conditions: Obesity; Metabolic Syndrome

Summary: the purpose of this trial is to investigate the efficacy and safety of ggt on korean obese women with or without metabolic syndrome risk factors


Eligibility criteria:
inclusion criteria: * female aged 19 to 65 years * subject must included at least one or more of the following symptoms below; * bmi of 30 kg/㎡ or more; * bmi between 27 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose \> 126mg/dl at the screening visit * bmi between 27 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 exclusion criteria: * subjects who had experience with allergic reaction on investigational drug(any ingredients of ip) * subjects who has diabetes as comorbidity, had experienced the elevation of blood glucose by ephedrine * subjects who had experienced rash, rubefaction, or itchiness by ggt administration * subjects who usually feel fatigue due to hyperhidrosis * subjects who experienced other allergic reactions * subjects who had 10 percent reduction in body weight over 6 months * subjects who decided to quit smoking over the last 3 months or have irregular smoking habits * subjects who have endocrine diseases associated with weight gain, such as hypothyroidism, cushing's syndrome, etc. * subjects who have heart disease (heart failure, angina pectoris, myocardial infarction) * subjects who have uncontrolled hypertension despite the use of antihypertensive drugs (sbp \> 145 mmhg or dbp \> 95 mmhg) * subjects who have uncontrolled diabetes despite the use of drugs (fbs\>7.8 mmol/l (140 mg/dl)) * subjects who have severe renal disability (scr \> 2.0 mg/dl) * subjects who have severe liver disability (2.5 fold of normal high range value on alanine aminotransferase \[alt\], aspartate aminotransferase \[ast\], alkaline phosphatase \[alp\]) * subjects who have poor digestion(anorexia, stomach discomfort, nausea, vomiting etc) or have the history of eating disorder such as anorexia nervosa or bulimia nervosa, etc.(keat-26 \< 20) * 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 cns stimulant medication for weight loss * subjects who had a use of drugs that can increase blood pressure or heart rate within a week, such as, decongestants, cough, cold, allergy treatments that include the ingredients of phenylpropanolamine, ephedrine, pseudoephedrine * forbidden treatment (insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse) * subjects who have diseases that may occur hypokalemia (hypomagnesemia, bartter syndrome, gitelman syndrome, diseases that can cause high aldosteronism etc.) or have cardiac dysrhythmia * difficult to measure anthropometric dimensions because of anatomical change such as resection * history of weight loss surgery, such as bariatric surgery, etc. * edema or dysuria * malignant tumour or lung disease * cholelithiasis * history of narrow angle glaucoma * subjects who have nervous or psychological medical history or presently suffer from the following diseases: depression, manic disorder, bipolar disorder, schizophrenia, epilepsy, alcoholism, anorexia, hyperphagia, etc. * subjects who have history of stroke or temporary ischemic cardioplegia * 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, iud, spermicide, condom, abstinence, etc.) * use of other investigational product within last 1 month

Keywords: obesity metabolic syndrome traditional korean medicine galgeun-tang