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Clinical Study on Chaiqin Chengqi Decoction in Treating Acute Gastrointestinal Function Injury Secondary to Sepsis: A Prospective, Multicenter, Randomized Controlled Study

Clinical Study on Chaiqin Chengqi Decoction in Treating Acute Gastrointestinal Function Injury Secondary to Sepsis: A Prospective, Multicenter, Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081778
Enrollment
Unknown
Registered
2024-03-11
Start date
2024-03-18
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Sepsis

Interventions

Experimental group:Prepare Chaiqin Chengqi decoction and take 80ml Q6h orally or gastric tube infusion. The temperature of the drug is maintained at 32-40 ?. Medication will be suspended at AGI level
Control group:Prepare a placebo and inject 80ml Q6h orally or through a gastric tube. The temperature of the drug is maintained at 32-40 ?. Medication will be suspended at AGI level 4. For patients wi

Sponsors

Suining Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria for sepsis, according to the 2016 3.0 sepsis diagnostic criteria (Singer et al., 2016), have a Sequential Organ Failure Assessment Score (SOFA) of = 2 points. (2) Simultaneously present with acute gastrointestinal injury (diagnosis and grading based on the guidelines developed by the ESICM Abdominal Issues Working Group). (3) Age 18 and above, regardless of gender. (4) Willing to participate in the experiment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) patients with malignancy. (2) Pregnant and lactating patients. (3) Gastrointestinal bleeding, mechanical intestinal obstruction, gastrointestinal necrosis, perforation. (4) Patients with varying degrees of mental disorders or mental illnesses. (5) Individuals with allergies to traditional Chinese medicine or other adverse reactions to traditional Chinese medicine.(6) Emergency surgical patients are required immediately upon admission.

Design outcomes

Primary

MeasureTime frame
AGI classification;intra-abdominal pressure;IAP;Sepsis score (SOFA);APACHE? score ;mortality;Start time of enteral nutrition;

Secondary

MeasureTime frame
Parenteral nutrition time;Antibiotic usage time;Anal exhaust time;Anal defecation time;Total hospitalization time;ICU stay time;white blood cell count;C-reactive protein;Procalcitonin;interleukin-6;

Countries

China

Contacts

Public ContactXiaodi Li

Suining Central Hospital

648957688@qq.com+86 186 8252 6633

Outcome results

None listed

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