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Table 1 Inclusion and exclusion criteriaa

From: A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial

Criteria

Inclusion criteria

1. Men and women ages 18 to 65 years

2. Individuals who meet one of the following criteria:

   2.1. BMI ≥ 30 kg/m2

   2.2. BMI 27 to 30 kg/m2 with hypertension at a proper treatment- and blood pressure-controlled 95 to 145 mmHg

   2.3. BMI 27 to 30 kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8 mmol/L (140 mg/dl)

   2.4. BMI 27 to 30 kg/m2 with hyperlipidaemia in a proper treatment regimen

   2.5. BMI 27 to 30 kg/m2 and ≥ 236 mg/dl total cholesterol or ≥ 150 mg/dl triglycerides at screening

3. Agreed to low-calorie diet during the trial

4. Written informed consent for participation in the trial

5. Written informed consent for the genetic test

Exclusion criteria

1. Endocrine disease such as hypothyroidism or Cushing syndrome

2. Heart disease (heart failure, angina pectoris and/or 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 the normal high range value for ALT, AST and ALP)

8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8 mmol/L (140 mg/d or over

9. Narrow-angle glaucoma

10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia and so on)

11. History of stroke or temporary ischaemic cardioplegia

12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa

13. Use of medication within the past 3 months that could have an effect on weight (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having an effect on absorption, metabolism and excretion)

14. Use of β-blocker or diuretic as hypertension medication within the past 3 months

15. Use of central nervous system medications or central nervous system stimulating weight reduction medications

16. Forbidden treatments (insulin, hypoglycaemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic and concerns related to medication abuse)

17. Difficult-to-measure anthropometric dimensions due to anatomical changes such as resection surgery

18. History of weight reduction surgery, bariatric surgery and so on

19. Unable to follow instructions during the trial as judged by the investigator

20. Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception (birth control pill, hormone implant, IUD, spermicide, condom, abstinence and so on) (women of child-bearing age indicated to be within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, and so on)

21. Use of other investigational products within the past month

22. Weight reduction > 10% within the past 6 months

23. Cessation of smoking within past 3 months or an irregular smoking habit

  1. a ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, DBP diastolic blood pressure, IUD intrauterine device; SBP systolic blood pressure, sCr, serum creatinine