Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1817 participants
INTERVENTIONAL
2017-10-20
2020-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention Group
100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.
Xuebijing Injection
100ml Xuebijing Injection every 12 hours for 5 days
Placebo group
normal saline 200 mL every 12 hours for 5 days
normal saline
200ml normal saline every 12 hours for 5 days
Interventions
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Xuebijing Injection
100ml Xuebijing Injection every 12 hours for 5 days
normal saline
200ml normal saline every 12 hours for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18≤ age ≤75years
3. 2 ≤SOFA ≤13
4. obtain informed consent
Exclusion Criteria
2. Pregnant and lactating women;
3. Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV);
4. Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);
5. Use of an immunosuppressant or having an organ transplant within the previous 6 months;
6. Participating in other clinical trials in the previous 30 days.
18 Years
75 Years
ALL
No
Sponsors
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National Health and Family Planning Commission, P.R.China
OTHER_GOV
Southeast University, China
OTHER
Responsible Party
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Songqiao Liu
Principle investigator
Principal Investigators
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Qiu Haibo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Southeast University
Locations
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Zhongda Hospital
Nanjing, Jiangsu, China
Countries
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References
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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.
Study Documents
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Document Type: Clinical Review& Education
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;315(8):801-10.
View DocumentOther Identifiers
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2017ZDSYLL025-P01
Identifier Type: -
Identifier Source: org_study_id
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