Table 4.
Study schedule of TJ001 clinical trial (12 weeks)a
| Initial screening b | Treatment period | ||||
|---|---|---|---|---|---|
| Measurement items | Visit 1 (-7 days) | Visit 2, week 0 (0 days) | Visit 3, 4 weeks (28 days) | Visit 4, 8 weeks (56 days) | Visit 5, 12 weeks (84 days) |
| Informed consent | Yes | ||||
| Demographic characteristicsc | Yes | ||||
| Vital signsd | Yes | Yes | Yes | Yes | Yes |
| Medical/drug use history | Yes | ||||
| Smoking/drinking status | Yes | Yes | Yes | Yes | |
| Physical examinatione | Yes | Yes | Yes | Yes | Yes |
| Laboratory testsf | Yes | Yes | |||
| Thyroid hormonesg | Yes | ||||
| Lipid test, CRP levelh | Yes | Yes | |||
| Abdominal computed tomography for body fat | Yes | Yes | |||
| Blood sample for genetic test | Yes | ||||
| Electrocardiography | Yes | ||||
| Pregnancy test | Yes | Yes | Yes | ||
| Inclusion/exclusion criteria check | Yes | ||||
| Dietary intake measurementi | Yes | Yes | Yes | Yes | |
| Concomitant medication | Yes | Yes | Yes | Yes | |
| Adverse event | Yes | Yes | Yes | ||
| Questionnairesj | Yes | Yes | |||
| Questionnaire for Sasang | |||||
| Constitution Classification | Yes | ||||
| II | |||||
| Exterior Cold | |||||
| Disease induced from the | Yes | Yes | Yes | Yes | |
| Esophagus affected by | |||||
| Cold' questionnaire in Tae-Eum-In persons Compliance calculation | Yes | Yes | Yes | ||
aCRP C-reactive protein. bThe initial screening is performed within 1 week of the start of the study period. The visit windows for each participant are ± 3 days. cSex, date of birth, age, contact address and telephone number. dBlood pressure (mmHg), pulse (beats/minute) and body temperature (°C). eBody weight (kg), height (cm), waist circumference (cm) and hip circumference (cm). fBlood tests are performed for haemoglobin, hematocrit, red blood cell count, white blood cell count, platelet count, total protein, albumin, total bilirubin, alanine transaminase, aspartate transaminase, alkaline γ-glutamyltransferase, uric acid, blood urea nitrogen/creatinine ratio, fasting plasma glucose, creatinine kinase and urine test for colour, specific gravity, pH, protein, glucose, ketone, urobilinogen, bilirubin, nitrite, red blood cells and white blood cells. gThyroid-stimulating hormone and free thyroxine are measured at the time of screening. hTotal cholesterol (mg/dl), high-density lipoprotein cholesterol (mg/dl), triglyceride (mg/dl) and CRP. iRecorded in kilocalories using 24-hour dietary recall methods by a dietician or clinical research coordinator. jKorean obesity-related quality of life (KOQOL) scale and Korean version of Eating Attitudes Test-26 (KEAT-26).