Protocol of Trials within Cohorts on the Integrated traditional Chinese and western medicine in the treatment of chronic spontaneous urticaria (Preprint)

BACKGROUND Chronic spontaneous urticaria (CSU) is a common inflammatory skin disease with severe itching and wheals. About 1.4% population worldwide are affected. Neither Second-generation H1-receptor antagonists nor biological agent Omalizumab (OMA) have low efficacy rate. Previous studies indicate that Traditional Chinese Medicine combined with biological agents can improve efficacy and reduce the occurrence of side effects in inflammatory skin diseases. This study initiates a Trials within Cohorts (TwiCs) method study, aiming to confirm the efficacy and safety of the Shenqi Formula (SQF) combined with OMA for CSU treatment OBJECTIVE To confirm the efficacy and safety of the Shenqi Formula (SQF) combined with OMA for CSU treatment METHODS This study is a cohort-based trial method named TwiCs, in which the urticaria cohort was obtained starting in November 2019 at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. 92 patients in this cohort will be randomly allocated into two groups: the OMA combined with SQF group and the OMA group in a 1:1 ratio. Patients will receive a 24-week treatment with 16 weeks of follow-up. The primary outcome is the 7-day Urticaria Activity Score. RESULTS No results are available as data collection is ongoing. CONCLUSIONS No conclusions are available as data collection is ongoing. CLINICALTRIAL International Traditional Medicine Clinical Trail Registry, ITMCTR2025000308, Registered 28 January 2025, http://itmctr.ccebtcm.org.cn/zh-CN/UserPlatform