acute pancreatitis
Conditions
Interventions
control group:Conventional Western medicine treatment plus placebo.
Sponsors
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for Mild Acute Pancreatitis (MAP) or Moderately Severe Acute Pancreatitis (MSAP) as outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Pancreatitis (2021)." 2. Meet the diagnostic criteria for "Damp-Heat Binding Syndrome" as specified in the "Expert Consensus on the Diagnosis and Treatment of Acute Pancreatitis in Traditional Chinese Medicine (2023)." 3. Gastrointestinal Symptom Rating Scale (GSRS) score is = 1 point. 4. Age between 18 and 65 years old inclusive with no gender restrictions. 5. Willing to participate in this study and sign or have a legal representative sign the Informed Consent Form. 6. Agree to take effective contraceptive measures during the trial period.
Exclusion criteria
Exclusion criteria: 1. Patients who have already reached SAP. 2. Those treated with Chinese patent medicines after onset. 3. Individuals with known severe cardiovascular, respiratory, renal, hepatic, or hematologic disorders, severe immunodeficiency, malignant tumors, epilepsy, or other similarly serious diseases. 4. Use of probiotics, corticosteroids, or immunosuppressive drugs within the past month. 5. Presence of clear intestinal ischemia or obstruction, severe abdominal distension or abdominal compartment syndrome, active gastrointestinal bleeding, high gastrointestinal fistula without a satisfactory enteral feeding tube, or any other condition that would prevent administration of Chinese medicines or enteral nutrition via the gastrointestinal tract. 6. Pregnant or lactating women. 7. Anyone with a known hypersensitivity to any component of the investigational product or its excipients. 8. Patients currently enrolled in, or who have participated in, another clinical drug trial within the past 4 weeks. 9. Individuals with a suspected or confirmed history of alcohol or drug abuse. 10. Any other circumstance that, in the investigator's opinion, could reduce the likelihood of successful enrollment or complicate follow-up (e.g., frequent job-related relocation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Function Recovery Time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) syndromes score.;Diamine Oxidase;D-Lactic Acid;Systemic Inflammatory Response Score;Gastrointestinal Function Score;gut microbiota;Serum Endotoxin;Procalcitonin;Inflammatory Factors; | — |
Countries
China
Contacts
Public ContactLi Li
Southwest University of Medical Sciences Affiliated Traditional Chinese Medicine Hospital
Outcome results
None listed