A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, 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 Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors

Official Title
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A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -

Conditions
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Metabolic Syndrome, Obesity

Intervention / Treatment
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* Drug: Daesiho-tang
* Drug: Chowiseungcheng-tang
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged 18 to 65 years Subject must included at least one or more of the following symptoms below BMI of 30 kg/㎡ or more; BMI between 25 and 29.9kg/㎡ with hypertension, taking medication or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit BMI between 25 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit BMI 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 Exclusion Criteria: 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 (SCr > 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 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, IUD, 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

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daesiho-tang<br>Dose: 6g, three times a day, each taken before or between meals for 12 weeks | Drug: Daesiho-tang<br>* Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.<br>* Other names: Elsion Granule;|
| Experimental: Jowiseungcheung-tang<br>Dose: 6g, three times a day, each taken before or between meals for 12 weeks | Drug: Chowiseungcheng-tang<br>* Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.<br>* Other names: CST;|
| Placebo Comparator: Placebo<br>Dose: 6g, three times a day, each taken before or between meals for 12 weeks | Drug: Placebo<br>* Usage: 6g, 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 |  | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in body fat percentage |  | baseline, 4,8,12,16 weeks | 
| Changes from baseline in fat mass |  | baseline, 4,8,12,16 weeks | 
| Changes from baseline in Waist circumference |  | baseline, 4,8,12,16 weeks | 
| Changes from baseline in Waist/hip ratio |  | baseline, 4,8,12,16 weeks | 
| Changes from baseline in Body mass index |  | baseline, 4,8,12,16 weeks | 
| Changes from baseline in Lipid profile |  | Screening visit, 12 weeks | 
| Changes from baseline in C-reactive protein (CRP) |  | Screening visit, 12 weeks | 
| Changes from baseline in blood glucose |  | Screening visit, 12 weeks | 
| Changes from baseline in abdominal visceral fat area |  | baseline, 12 weeks | 
| Korean Obesity-related Quality of Life (QoL) scale |  | baseline, 12 weeks | 
| Korean version of Eating Attitudes Test-26 |  | baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, Daesiho-tang, Taeeumjowi-tang, Korean medicine