Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

Kyung Hee University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity

Treatments: Drug: Euiiyin-tang; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01724099

HP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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149 participants in 2 patient groups, including a placebo group

Euiiyin-tang

Experimental group

Description:

powder type, 3 times per day before the meal, 12 weeks total

Treatment:

Drug: Euiiyin-tang

Placebo

Placebo Comparator group

Description:

powder type, 3 times per day before the meal, 12 weeks total

Treatment:

Drug: Placebo