Table 2 Exclusion criteria
From: Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial
Criteria for exclusion of participants |
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1. Patients with endocrine disease such as hypothyroidism, Cushing’s syndrome, etc., conditions that could affect patient weight |
2. Patients with heart disease (heart failure, angina pectoris, and myocardial infarction) |
3. Patients with uncontrolled hypertension (SBP >145 mmHg or DBP >95 mmHg |
4. Patients with malignant tumour or lung disease |
5. Patients with cholelithiasis |
6. Patients with severe renal disability (serum creatinine (SCr) > 2.0 mg/dL) |
7. Patients with severe liver disability (2.5 times higher than the maximum value in normal group on alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) |
8. Patients with insulin-independent diabetes mellitus, with fasting blood sugar more than 7.8 mmol/L (140 mg/dL) |
9. Patients with narrow angle glaucoma |
10. Patients with history of neurological or psychological disease or currently suffering from such diseases (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.) |
11. Patients with history of stroke or temporary ischaemic cardioplegia |
12. Patients with history or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc. |
13. Patients with experience of medications that could have an effect on weight within last 3 months such as appetite suppressant, laxative, or oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medications affecting absorption, metabolism, and excretion |
14. Patients under administration of central nervous system or central active weight reduction medications |
15. Patients with experience of β-blocker or diuretic as hypertension medication within last 3 months |
16. Forbidden treatments (insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication abuse concerns) |
17. Patients having difficulty with body measurements due to anatomical change such as resection |
18. Patients with experience of surgical history for weight reduction; bariatric surgery, etc. |
19. Patients judged unable to follow instructions of the trial by clinical trial investigators |
20. Women of childbearing age who are pregnant, breastfeeding, planning a pregnancy, or who do not agree to use proper contraceptive methods (birth control pills, hormone implant, intrauterine device (IUD), spermicide, condom, abstinence, etc.). (Women of childbearing age refers to those within 2 years of menopause who have not had a hysterectomy, bilateral tubal ligation, bilateral oophorectomy, etc.) |
21. Patients who have used other test products within the past month |
22. Patients who have experienced a 10% weight reduction within the past 6 months |
23. Those who decided to stop smoking within the last 3 months or who have an irregular smoking habit |