Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyunghee University Medical Center
• Collaborators: Gachon University Gil Medical Center; Korea Health Industry Development Institute

Criteria

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