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.