Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a superior reduction compared to those taking the placebo.

Detailed Description
-----------------
This study has two arms, Euiiyin-tang and placebo group. Inclusion of 80 patient each arm. They will be screened at first visit. At the baseline, that is the second visit, they will be evaluated each outcomes including weight, waist circumference, lipid profile (total cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and eating attitudes, etc. The Euiiyin-tang will provide to the patients from the baseline, it contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be repeated except lipid profile, CRP, abdominal CT. Another Euiiyin-tang of 4 weeks will be given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes, etc.

Official Title
-----------------
A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Euiiyin-tang
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-65 years old Patients applying to one of the followings 2.1. BMI 30kg/m2 or over 2.2. BMI 27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.3. BMI 27-29.9kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8mmol/L(140mg/dL) 2.4. BMI 27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.5. BMI 27-39.9kg/m2 and Total cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening Agreed to low-calorie diet during the trial Written informed consent of the trial Exclusion Criteria: Endocrine disease such as hypothyroidism, Cushing's syndrome, etc. Heart disease (heart failure, angina pectoris, myocardial infarction) Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg) Malignant tumour or lung disease 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) Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over Narrow angle glaucoma History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.) History of stroke or temporary ischemic cardioplegia History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc. Use of medication that could have effect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having effect on absorption, metabolism, excretion) Use of β--blocker or diuretic as hypertension medication within last 3 months Use of medication for central nervous system or central active weight reduction medication Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse) Difficult to measure anthropometric dimensions because of anatomical change such as resection Surgical history for weight reduction; bariatric surgery, etc. Unable to follow instructions of the trial as judged by investigator Women who were pregnant, lactating, planning a pregnancy or women of childbearing age who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.) (Women of childbearing age indicate within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, etc.) Use of other investigational product within last 1 month Reduction over 10% of the previous weight within 6 months Decided to stop smoking within last 3 months; however, keeping irregular smoking habit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Euiiyin-tang<br>powder type, 3 times per day before the meal, 12 weeks total | Drug: Euiiyin-tang<br>* Korean medicinal herbal drug<br>|
| Placebo Comparator: Placebo<br>powder type, 3 times per day before the meal, 12 weeks total | Drug: Placebo<br>* Placebo drug, same odor and formula as Euiiyin-tang<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight reduction |  | between baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CRP) |  | baseline and 12 weeks | 
| Blood pressure |  | baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Blood glucose |  | baseline and 12 weeks | 
| Waist/hip ratio |  | 4 weeks, 8 weeks, and 12 weeks | 
| Waist circumference |  | baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Korean Obesity-related Quality of Life scale |  | baseline and 12 weeks | 
| Korean version of Eating Attitudes Test-26 |  | baseline and 12 weeks | 
| Total cholesterol |  | baseline and 12 weeks | 
| Triglyceride |  | baseline and 12 weeks | 
| Visceral fat area | Using abdominal computed tomography | baseline and 12 weeks | 
| Subcutaneous fat area | Using abdominal computed tomography | baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Herbal product, Korean Medicine