Skip to main content

Table 4 Study schedule of TJ001 clinical trial (12 weeks)a

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

 

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

  1. a CRP 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).
Back to article page

Trials

ISSN: 1745-6215