The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study

Table 4 Study schedule. A brief study schedule at every visit

	Screening* Visit 1	Baseline Visit 2	Visit 3	Visit 4	Follow up (Visit 5)
	D-21 ~D-1	D0 Week 0	D21 Week 3	D42 Week 6	D56 Week 8
Informed consent form	●
Demographic information taking ¹	●
Medical history taking	●
Finger-prick blood glucose testing	●
QSCC II ²	●
Inclusion/exclusion criteria check	●
Physical examination ³	●	●	●	●
Vital sign measurement ⁴	●	●	●	●
Laboratory test ⁵	●	●	●	●
VAS ⁶	●	●	●	●
Electrocardiogram(ECG)	●			●
Concomitant drugs check	●	●	●	●
Treating physician examination ⁷	●	●	●	●
Adverse event monitoring			●	●	●
Compliance checking			●
Study drug distribution		●	●
Smoking, drinking, coffee taking status ⁸	●
Diet, physical exercise Counseling ⁸		●	●

●: Item need to be carried out during the visit.
* required to fast from 10 p.m. the day before the test prior to the blood sample collection.
¹ sex, date of birth, age, contact address and phone number.
² Questionnaire for the Sasang Constitution Classification II
³ body weight(kg), height(cm), waist circumference(cm), hip circumference(cm).
⁴ blood pressure(mmHg), pulse(/min), body temperature(°C).
⁵ blood test (WBC, RBC, hemoglobin(HGB), hematocrit(HCT), platelet count(PLT), AST, ALT, γ-GTP, total bilirubin, albumin, total protein, total cholesterol, triglyceride, HDL cholesterol, BUN, creatinine, glucose(fasting), 2h-OGTT glucose, HbA1c, fructosamine, insulin(fasting)), urine test.
⁶ visual analogue scale: polydipsia, polyuria, polyphasia, fatigue.
⁷ includes present illness, past history taking.
⁸ risk factors such as smoking, alcohol drinking, severe exercise and other drug intake will be managed strictly.

ISSN: 1745-6215