TABLE 1.
Trial processes chart.
Period | Enrollment | Baseline | Treatment | Follow-up | ||
---|---|---|---|---|---|---|
Time points | Week -1 | Week 0 | Week 4 | Week 8 | Week 12 | Week 16 |
Patients | ||||||
Medical history | √ | |||||
Physical examination | √ | √ | ||||
Laboratory examination | √ | √ | ||||
Informed consent | √ | |||||
Randomization | √ | |||||
Intervention | ||||||
HongHua XiaoYao Pills (HHXYP) group | 0.39g/pill, 2 pills, three times daily | |||||
Oryzanol Control (OC) group | 10mg/pill, 2 pills, three times daily | |||||
Outcomes | ||||||
the modified Kupperman Index (KI) | √ | √ | √ | √ | √ | √ |
Hot flash scale (HFs) | √ | √ | √ | √ | √ | √ |
MENQOL | √ | √ | √ | |||
HAMD | √ | √ | √ | |||
HAMA | √ | √ | √ | |||
Serum E2, FSH and LH levels | √ | √ | ||||
Serum NE, 5-HT and DA levels | √ | √ | ||||
Serum NO, ET-1 and CGRP levels | √ | √ | ||||
Expression of PI3K, Akt, and pAkt | √ | √ | ||||
Trial evaluation | ||||||
Safety of medicine | √ | √ | √ | √ | ||
Adverse event | √ | √ | √ | √ | ||
Reasons of drop-outs or withdrawals | √ | √ | √ | |||
Patient’s compliance | √ |
E2, estradiol; FSH, follicle-stimulating hormone; LH, luteinizing hormone; NO, nitric oxide; ET-1, endothelin-1; CGRP, calcitonin gene-related peptide; NE, norepinephrine; 5-HT, serotonin; DA, dopamine; PI3K, phosphatidylinositol 3-active enzyme; Akt, protein activator enzyme B; pAkt, phosphorylated protein kinase B.