Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

Kyunghee University Medical Center149 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

149

Conditions

Obesity

Interventions

Euiiyin-tangDRUG

Korean medicinal herbal drug

PlaceboDRUG

Placebo drug, same odor and formula as Euiiyin-tang

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women aged 18-65 years old 2. 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 3. Agreed to low-calorie diet during the trial 4. Written informed consent of the trial Exclusion Criteria: 1. Endocrine disease such as hypothyroidism, Cushing's syndrome, etc. 2. Heart disease (heart failure, angina pectoris, myocardial infarction) 3. Uncontrolled hypertension (SBP \> 145 mmHg or DBP \> 95 mmHg) 4. Malignant tumour or lung disease 5. Cholelithiasis 6. Severe renal disability (SCr \> 2.0 mg/dL) 7. Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], alkaline phosphatase) 8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over 9. Narrow angle glaucoma 10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.) 11. History of stroke or temporary ischemic cardioplegia 12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc. 13. 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) 14. Use of β--blocker or diuretic as hypertension medication within last 3 months 15. Use of medication for central nervous system or central active weight reduction medication 16. Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse) 17. Difficult to measure anthropometric dimensions because of anatomical change such as resection 18. Surgical history for weight reduction; bariatric surgery, etc. 19. Unable to follow instructions of the trial as judged by investigator 20. 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.) 21. Use of other investigational product within last 1 month 22. Reduction over 10% of the previous weight within 6 months 23. Decided to stop smoking within last 3 months; however, keeping irregular smoking habit

Locations (1)

Gachon University Gil Medical Center

Incheon, South Korea

Outcomes

Primary Outcomes

Weight reduction

Time frame: between baseline and 12 weeks