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. 2022 Dec 8;13:1001228. doi: 10.3389/fphar.2022.1001228

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.