The efficacy and safety of a Korean traditional medicine named 'Taeumjowi-tang' on obese patients
- Conditions
- ObesityNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN87153759
- Lead Sponsor
- Korea Health Industry Development Institute (South Korea)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 104
1. Men or women aged 18-65 years old
2. Patients applying to one of the followings
2.1. BMI 30kg/m2 or over
2.2. BMI 27-30kg/m2 with hypertension in a proper treatment and blood pressure controlled 95-145mmHg
2.3. BMI 27-30kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8mmol/L(140mg/dL)
2.4. BMI 27-30kg/m2 with hyperlipidemia in a proper treatment
2.5. BMI 27-30kg/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
5. Written informed consent of the genetic test
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], Aspatate 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 B-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight reduction (over 5%), measured at baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method 1. Weight reduction, measured at baseline, 4, 8 and 12 weeks<br>2. Lipid profile and C-reactive protein (CRP), measured at baseline and 12 weeks<br>3. Blood pressure, measured at baseline and 12 weeks<br>4. Blood glucose, measured at baseline and 12 weeks<br>5. Waist/hip ratio, measured at baseline, 4, 8 and 12 weeks<br>6. Waist circumference, measured at baseline, 4, 8 and 12 weeks<br>7. Abdominal computed tomography, measured at baseline and 12 weeks<br>8. Korean Obesity-related Quality of Life (QoL) scale, measured at baseline and 12 weeks<br>9. Korean version of Eating Attitudes Test-26, measured at baseline and 12 weeks