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The effects of Wenchang Tongfu Decoction on the intestinal mucosal barrier and immune function in patients with sepsis-induced gastrointestinal dysfunction:A Single-Center, Double-Blind, Randomized Controlled Study

Clinical Study on the Improvement of Intestinal Mucosal Barrier and Immune Function in Patients with sepsis-induced Gastrointestinal Dysfunction by Wenchang Tongfu Decoction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077335
Enrollment
Unknown
Registered
2023-11-06
Start date
2023-11-07
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis-induced gastrointestinal dysfunction

Interventions

treatment group:Conventional Western medicine treatment + Wenchang Tongfu Decoction 10g(+warm water 50ml) nasogastric feeding q4h and 20g(+warm water 150ml) ml enema q6h for 3 days
control group:Conventional Western medicine treatment + placebo10g(+warm water 50ml) nasogastric feeding q6h and 10g(+warm water 150ml) ml enema q6h for 3 days

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) In accordance with the western medicine diagnostic criteria of sepsis-induced Gastrointestinal Dysfunction; (2)Traditional Chinese Medicine (TCM) syndrome differentiation identifies the pattern as "Yangxu of Pishen,Yuxue Fushi" (3) Estimated ICU length of stay = 72 hours; (4) Age 18-85 years (inclusive), gender not limited; (5) Sign informed consent form.

Exclusion criteria

Exclusion criteria: (1) Gastrointestinal dysfunction caused by gastrointestinal surgery; (2) Patients with contraindications to enteral nutrition and enema, or mechanical intestinal obstruction; (3) Individuals allergic to medications used in the protocol; (4) Pregnant or lactating women; (5) Engaged in other drug research at the time of enrollment; (6) Presence of other factors that may affect the examination or treatment efficacy.

Design outcomes

Primary

MeasureTime frame
diamine oxidase;

Secondary

MeasureTime frame
D-lactic acid;lymphocyte count;CD4+/CD8+ T cell ratio;total levels of IgG, IgM, and IgA ;28-day mortality rate;reflux volume;time to resolution of vomiting;time to resolution of bowel sounds;number of bowel movements per day;

Countries

China

Contacts

Public ContactKaichen Zhang

Hospital of Chengdu University of Traditional Chinese Medicine

15281090419@163.com+86 152 8109 0419

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026