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. 2023 Jul 7;14:1190663. doi: 10.3389/fphar.2023.1190663

TABLE 1.

Study visit phase 2.

Action visit V1# V2 V3 V4 V5 V6 V7 V8 V9# V10 V11 V12 V13#
Day 1 2 3 4 5 9 16 23 30 37 44 51 60
Briefing x
Informed consent x
Subject Diary a x
Case Report Form (CRF) b x
Vital sign (BP, pulse) x x x x x x x x x x x x x
Height measurement x x x x x x x x x x x x x
Weight measurement x x x x x x x x x x x x x
Blood sampling x x x
Capsule consumed in front of trial staffs x x x x x x x x x x x x
Restock stock supply c x x x x x x x x
Medical examination and doctor consultation x x x
Adverse event assessment d x x x x x x x x x x x x x

Abbreviation: BP, (Blood pressure).

# Intervention days (day 1, day 30, day 60): Volunteers were reminded a day prior to fast for 8 h before appointment time for blood collection. Medical examination and doctor consultation were mandatory. Data was recorded in CRF, distributed on day 1.

a

Subject diary was given to be kept by the volunteers to record the time the capsule was consumed, reason(s) if the capsule was not taken within the 60 days, intake of another drug/supplement and the reason(s).

b

Case Report Form (CRF) is an official document to record demographic information, medical history, drugs/supplements intake, adverse events occurred during the trials (if any), and other important information. CRF was first given to the volunteers to ensure demographic information was correctly written. The volunteers returned the CRF during their first medical examination to the appointed physicians, and the CRF was stored in the CTW throughout entire trial duration.

c

The volunteers were not required to come on weekend, hence supply was given on Friday (first week). Then, starting from the second week, the volunteers were only required to come once a week to get a 1-week stock supply.

d

Any adverse events that occurred throughout the entire trial period were investigated and recorded into CRF.