Period | Screening | Treatment | Follow-up | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 |
Week | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 13 | ||||||||
Enrollment: | |||||||||||||||||||
Informed consent | × | ||||||||||||||||||
Demographic characteristics | × | ||||||||||||||||||
Medical history | × | ||||||||||||||||||
Vital signs | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × |
Physical examination | × | × | |||||||||||||||||
Lab test | × | × | |||||||||||||||||
Inclusion/exclusion criteria | × | ||||||||||||||||||
Randomization | × | ||||||||||||||||||
Intervention: | |||||||||||||||||||
Pharmacopuncture group | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | ||
Control group | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | ||
Assessment: | × | × | × | × | × | ||||||||||||||
Hot Flash Score | × | × | × | × | × | × | × | × | × | × | × | ||||||||
Menopause Rating Scale | × | × | × | × | |||||||||||||||
Adverse events | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × | × |