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

Gachon University Gil Oriental Medical Hospital

Status

Completed

Conditions

Obesity

Metabolic Syndrome

Treatments

Drug: GGT

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03479346

ISEE_2017_GGT

Details and patient eligibility

About

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

Enrollment

140 patients

Sex

Female

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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