NCT07069894

Brief Summary

Xuebijing injection (XBJ) showed proven efficacy in the EXIT-SEP trial (NCT03238742), lowering 28-day mortality. However, its real-world effectiveness requires validation due to the trial's strict criteria. Broader clinical evaluation is imperative.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,400

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Aug 2025Sep 2027

First Submitted

Initial submission to the registry

June 30, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

June 30, 2025

Last Update Submit

July 15, 2025

Conditions

Sepsis

Keywords

SepsisXuebijing injectionIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 28-day all-cause mortality

    28 days after enrollment

Secondary Outcomes (3)

  • ICU mortality

    From Intensive Care Unit (ICU) admission to ICU discharge or death, up to 28 days.

  • Ventilator-free days

    28 days after enrollment

  • ICU-free days within 28 days

    28 days after enrollment

Study Arms (1)

Xuebijing Group

The Xuebijing group consisted of sepsis patients who received both Xuebijing injection and guideline-concordant therapy. Researchers did not provide any additional interventions, but instead observed and documented the clinical outcomes and treatment effects of Xuebijing injection in combination with standard therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission

You may qualify if:

  • Hospitalized patients aged ≥18 years
  • Sepsis diagnosis meeting Sepsis-3 criteria
  • Informed consent signed by patient or legally authorized representative

You may not qualify if:

  • Patients with a prior history of sepsis
  • Sepsis diagnosis \>48 hours prior to enrollment
  • Current participation in clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (7)

  • Ma Q, Qiu M, Zhou H, Chen J, Yang X, Deng Z, Chen L, Zhou J, Liao Y, Chen Q, Zheng Q, Cai L, Shen L, Yang Z. The study on the treatment of Xuebijing injection (XBJ) in adults with severe or critical Corona Virus Disease 2019 and the inhibitory effect of XBJ against SARS-CoV-2. Pharmacol Res. 2020 Oct;160:105073. doi: 10.1016/j.phrs.2020.105073. Epub 2020 Jul 9. No abstract available.

    PMID: 32653650BACKGROUND

  • Liu X, Song Y, Guan W, Qiu H, Du B, Li Y, Liu Y, Shang H, Zhong N, Coronavirus Disease Emergency Project Research Collaboration G. [A multicenter prospective cohort study of Xuebijing injection in the treatment of severe coronavirus disease 2019]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Jul;33(7):774-778. doi: 10.3760/cma.j.cn121430-20210514-00714. Chinese.

    PMID: 34412743BACKGROUND

  • Song Y, Yao C, Yao Y, Han H, Zhao X, Yu K, Liu L, Xu Y, Liu Z, Zhou Q, Wang Y, Ma Z, Zheng Y, Wu D, Tang Z, Zhang M, Pan S, Chai Y, Song Y, Zhang J, Pan L, Liu Y, Yu H, Yu X, Zhang H, Wang X, Du Z, Wan X, Tang Y, Tian Y, Zhu Y, Wang H, Yan X, Liu Z, Zhang B, Zhong N, Shang H, Bai C. XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial. Crit Care Med. 2019 Sep;47(9):e735-e743. doi: 10.1097/CCM.0000000000003842.

    PMID: 31162191BACKGROUND

  • 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.

    PMID: 37126332BACKGROUND

  • Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155.

    PMID: 31804299BACKGROUND

  • Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

    PMID: 31954465BACKGROUND

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Professor Liu Songqiao

CONTACT

+86 25 83262553liusongqiao@ymail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 17, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

CN(1)