Period | Screening | Active treatment | F/U | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Visit | Screening | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9* | 10 |
Week | 0 | 1 | 2 | 3 | 4 | 12 | |||||
Consent | † | ||||||||||
Demographic survey | † | ||||||||||
Medical history | † | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | † | † |
Vital signs | † | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | † | |
Physical examination | † | ||||||||||
Conformity assessment | † | ||||||||||
Check PSA | † | ||||||||||
Check prostate size (TRUS) | † | ||||||||||
Inclusion/exclusion criteria | † | ||||||||||
Inform patient of the visit schedule | † | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | |
Randomisation | † | ||||||||||
Moxibustion | † | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ||
IPSS | † | ‡ | † | † | |||||||
SF-36 | † | ‡ | † | † | |||||||
PGIC | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | † | † | ||
Qmax | † | † | |||||||||
PVR | † | † | |||||||||
FVC | † | † | |||||||||
Adverse event monitoring | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | ‡ | |
Final compliance assessment | † |
*Visit 9: 1–3 days after visit 8.
†Both integrative group and conventional group.
‡Integrative group.
FVC, frequency–volume chart; IPSS, International Prostate Symptom Score; SF-36, Short-Form 36-Question Health Survey; PGIC, patient’s global impression of changes; PSA, prostate-specific antigen; PVR, post-void residual urine volume; Qmax, maximum urinary flow rate; TRUS, transrectal ultrasonography.