The Efficacy of Xuebijing Injection on Sepsis

Phase 4 Completed 1817 enrolled Southeast University, China National Health and Family Planning Commission, P.R.China · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

Timeline

Start: 2017-10-20
Primary completion: 2019-07-28
Completion: 2020-01-08

Outcome

Met primary endpoint

paper between the placebo group and the XBJ group (230 of 882 patients [26.1%] vs 165 of 878 patients [18.8%], respectively; P < .001). PMID 37126332 ↗

paper the administration of XBJ reduced 28-day mortality compared with placebo. PMID 37126332 ↗

Publications

Lou X, Chen H, Shi N, Yu R, Li S, Yang Y, Liu S, Xie J, Qiu H. Treatment effects of Xuebijing injection in patients with sepsis by clinical phenotype: a post hoc analysis of the EXIT-SEP trial. EClinicalMedicine. 2025 Jul 9;86:103341. doi: 10.1016/j.eclinm.2025.103341. eCollection 2025 Aug.
Liu S, Yao C, Xie J, Liu H, Wang H, Lin Z, Qin B, Wang D, Lu W, Ma X, Liu Y, Liu L, Zhang C, Xu L, Zheng R, Zhou F, Liu Z, Zhang G, Zhou L, Liu J, Fei A, Zhang G, Zhu Y, Qian K, Wang R, Liang Y, Duan M, Wu D, Sun R, Wang Y, Zhang X, Cao Q, Yang M, Jin M, Song Y, Huang L, Zhou F, Chen D, Liang Q, Qian C, Tang Z, Zhang Z, Feng Q, Peng Z, Sun R, Song Z, Sun Y, Chai Y, Zhou L, Cheng C, Li L, Yan X, Zhang J, Huang Y, Guo F, Li C, Yang Y, Shang H, Qiu H; EXIT-SEP Investigators. Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis: The EXIT-SEP Randomized Clinical Trial. JAMA Intern Med. 2023 Jul 1;183(7):647-655. doi: 10.1001/jamainternmed.2023.0780.
Liu S, Yao C, Zhang J, Yang Y, Qiu H; EXIT-SEP Investigators. Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial. BMJ Open. 2019 Aug 28;9(8):e028664. doi: 10.1136/bmjopen-2018-028664.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Xuebijing	Traditional medicine (herbal / TCM)	100 ml	Intravenous