Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial

Table 2

Outcome measures.

Domain	Measure	Time (weeks)
Primary
Mean pain intensity of headache change	10 cm VAS with “none” and “very severe” at either end	0, 1, 2, 4, 8, 12
Secondary
AUC	Calculated by the sum of the daily headache duration (hours) multiplied by the daily headache intensity in each observed period and, then, divided by the observation period	0, 1, 2, 4, 8, 12
Headache frequency	Defined as a ≥50% reduction by the number of days with a headache or attacks per evaluation period; headache hours for each observed period	0, 1, 2, 4, 8, 12
Headache hours	The total hours in each observed period	0, 1, 2, 4, 8, 12
Rescue medication use	Records the number of participants using the rescue medication and the total dosage per week	0, 1, 2, 4, 8, 12
QBS measurement	Evaluated by a qualified CM physician	0, 1, 2, 4, 8, 12
Quality of life	EQ-5D-5L	0, 4, 12
Global evaluation of medication	A simple verbal scale: very poor, poor, neutral, good, very good	4
Health economic indexes	Registration costs, laboratory tests, drugs (other than the experimental drug), hospital admission, transportation, average monthly income, costs incurred by family caregivers	0, 1, 2, 4

VAS: visual analogue scale, AUC: area-under-the-headache curve. EQ-5D-5L: EuroQol-5-Dimensions-5-Level.