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.