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

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