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

Study Overview
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Brief Summary
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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

Official Title
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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
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Obesity, Metabolic Syndrome

Intervention / Treatment
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* Drug: GGT
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GGT group<br>Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. | Drug: GGT<br>* Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.<br>* Other names: Galgeun-tang;|
| Placebo Comparator: Placebo group<br>Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd. | Drug: Placebo<br>* Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in body weight | Estimated mean changes from baseline in body weight after 12 weeks of treatment. | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in body fat percentage | Estimated mean changes from baseline in body fat percentage at different time points during treatment period | baseline, 4,8,12 weeks | 
| Changes from baseline in fat mass | Estimated mean changes from baseline in fat mass at different time points during treatment period | baseline, 4,8,12 weeks | 
| Changes from baseline in Waist circumference | Estimated mean changes from baseline in Waist circumference at different time points during treatment period | baseline, 4,8,12 weeks | 
| Changes from baseline in Waist/hip ratio | Estimated mean changes from baseline in Waist/hip ratio at different time points during treatment period | baseline, 4,8,12 weeks | 
| Changes from baseline in Body mass index | Estimated mean changes from baseline in Body mass index at different time points during treatment period | baseline, 4,8,12 weeks | 
| Changes from baseline in Lipid profile | Estimated mean changes from first visit in Lipid profile after 12 weeks of treatment. | Screening visit, 12 weeks | 
| Changes from baseline in C-reactive protein (CRP) | Estimated mean changes from baseline in C-reactive protein (CRP) after 12 weeks of treatment. | baseline, 12 weeks | 
| Changes from baseline in blood glucose | Estimated mean changes from first visit in blood glucose after 12 weeks of treatment. | Screening visit, 12 weeks | 
| European Quality of life 5 Dimension(EQ5D) | EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem). | baseline, 12 weeks | 
| Changes from baseline in serum leptin | Estimated mean changes from first visit in serum leptin after 12 weeks of treatment. | baseline, 12 weeks | 
| Korean version of Western Ontario and McMasters Universities Oateoarthritis Index | Determination of patient's knee function and pain | baseline, 12, 16 weeks | 
| cost per QALY(Quality Adjusted Life Years) gained | The cost per QALY gained is calculated according to normal health-economic evaluation models. | 6 months or 1 year | 
| Economic evaluation (medical costs) | Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups. | baseline, 4,8,12,16,20,24 weeks | 
| Economic evaluation (time-related costs) | Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups. | baseline, 4,8,12,16,20,24 weeks | 
| Economic evaluation (lost productivity costs) | Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups. | baseline, 4,8,12,16,20,24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Metabolic syndrome, Traditional Korean Medicine, Galgeun-tang