Time point | Enrolment | Baseline | Treatment phase | Follow-up phase | ||||
Week -1 | Week 0 | Week 2 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | |
Screening and enrolment | ||||||||
Clinical interview | × | |||||||
Laboratory test | × | × | ||||||
Eligibility screen | × | |||||||
Informed consent | × | |||||||
Randomisation | × | |||||||
Interventions | ||||||||
Acupuncture | 16 sessions treatment | |||||||
Sham acupuncture | 16 sessions treatment | |||||||
Waiting-list | No acupuncture treatment | |||||||
Assessments | ||||||||
Primary outcome | ||||||||
UAS7 | × | × | × | × | × | × | × | |
Secondary outcomes | ||||||||
VAS for itch-severity | × | × | × | × | × | × | × | |
DLQI | × | × | × | × | × | × | × | |
HAMD | × | × | × | × | ||||
HAMA | × | × | × | × | ||||
PSQI | × | × | × | |||||
Serum total IgE | × | × | ||||||
Others | ||||||||
Adverse events | × | × | × | × | × | × | ||
Blinding assessment | ×* | × | ||||||
Expectancy questionnaire | × | |||||||
Treatment effects self-assessment | × | |||||||
Patients’ compliance | × | |||||||
Medicine alliance | × | × | × | × | × | × | × |
*Assessed after the first session of acupuncture treatment.
DLQI, Dermatology Life Quality Index; HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale; IgE, imunoglobulin E; PSQI, Pittsburgh Sleep Quality Index; UAS7, Urticaria Activity Score for 7 consecutive days; VAS, visual analogue scale.