Efficacy and Safety of Da-Cheng-Qi Decoction in Severe Acute Pancreatitis

Rationale: DCQD, recorded in the Shang Han Lun, is a classical purgative formula. This trial is the acute-stage component of the "Integrated Traditional Chinese and Western Medicine Whole-Stage Treatment Protocol for SAP" (parent study, 200 participants; Medical Research Filing No. MR-31-26-073582; ethics approval 2026-178; funding: Bureau-level project 2026150).

Why only the acute stage was randomized: DCQD is administered during the acute stage (within 72 h of onset), the stage at which prospective randomization is both feasible and scientifically meaningful. Once patients enter the infection stage (Huang-Qin Decoction combined with Du-Shen Decoction) and recovery stage (Si-Jun-Zi Decoction combined with Ban-Xia-Xie-Xin Decoction), allocation has been determined by the acute-stage randomization and the acute-stage intervention has already been administered; separate prospective trials for these stages would be neither feasible nor scientifically meaningful. No independent protocols exist for the later stages; their data are collected within the parent protocol.

Final attribution: Follow-up data from these 60 participants will be fully incorporated into the parent cohort (n = 200) for final analysis. This registration covers the acute-stage randomized comparison of DCQD versus standard Western treatment alone.

DCQD composition: Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine.

Inclusion criteria

• Severe acute pancreatitis diagnosed according to the revised Atlanta classification
• Age 18-80 years
• Disease onset within 72 h
• Intra-abdominal hypertension (IAP >= 12 mmHg) within 24 h of admission
• Written informed consent obtained

Exclusion criteria

• Age <18 or >80 years
• Pregnancy or lactation
• Advanced malignancy (pancreatic, hepatobiliary, or gastrointestinal)
• Severe chronic organ failure
• Autoimmune disease or immunosuppression
• Intra-abdominal hemorrhage
• Urinary tract infection or prior bladder surgery (precluding bladder manometry)
• Allergic constitution or known allergy to study medication
• Psychiatric illness