The effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

Table 1 Trial process chart

	Before baseline screening	Baseline	Visit 1 treatment phase	Visit 2 treatment phase	Visit 3 treatment phase	Visit 4 treatment phase	Visit 5 follow-up phase
		(before chemo)	Before 2nd chemo	Before 3rd chemo	Before 4th chemo	Before 5th chemo	1 month after chemo
Patients
Inclusion and exclusion criteria	×
Informed consent		×
Demographics		×
Medical characteristics	×	×	×	×	×	×	×
Randomization and allocation concealment		×
Primary outcomes
Grading of hair loss		×	×	×	×	×	×
Objective indices (hair quality and hair follicles)		×	×	×	×	×	×
Secondary outcomes
Facial color and thumbnail color		×	×	×	×	×	×
Grading of thumbnail ridging		×	×	×	×	×	×
Quality of life and fatigue		×	×	×	×	×	×
Routine blood test		×	×	×	×	×	×
Liver function (ALT, AST, total protein, and Alba)		×	×	×	×	×	×
Renal function (Cr, UA and BUN)		×	×	×	×	×	×
Kidney deficiency (IgM, C3、CD4 +, CD8 + Mg²⁺, Cu²⁺, Zn²⁺, Fe³⁺)		×		×		×
Adverse events			×	×	×	×	×
Patients’ diary records			Every day during the study

BUN blood urea nitrogen, Cr creatinine, ALT alanine aminotransferase, AST aspartate aminotransferase

ISSN: 1745-6215