Efficacy of DaXianXiong decoction in preventing the progression of severity of acute pancreatitis: Study protocol for a randomized controlled trial

I ntroduction: Developing countries are facing an increase in the incidence of acute pancreatitis (AP) — characterized by rapid onset, fast progression, high rate of severity, and high mortality. Progression of AP into severe acute pancreatitis (SAP) results in a series of complications such as organ dysfunction, local abscesses, pseudocysts, and necrosis. As no effective intervention measure has yet been developed, supportive therapy remains the major approach for the early treatment of AP. DaXianXiong decoction is a widely used TCM formulation; however, limited research is conducted on its clinical efficacy. Here, we propose a standardized clinical trial to evaluate the effectiveness and safety of DaXianXiong decoction in preventing the progression of AP to SAP. M ethods and analysis: This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. Sixty eligible patients will be randomly allocated in a 1:1 ratio to the intervention group and the control group. Both groups will receive standard Western medical treatment for pancreatitis. However, the intervention group will additionally receive DaXianXiong decoction, while the control group will receive a placebo similar to the decoction. The primary outcomes will include incidence of SAP, modified CTSI score, APACHE II score, Modified Marshall score, and levels of the inflammation factor. The secondary outcomes will include the effect of the gastrointestinal dysfunction treatment. Evaluations will be conducted at baseline, 24 h after intervention, and days 3, 7, and 28 after intervention in both groups. D iscussion: This trial will help us assess the effectiveness and safety of DaXianXiong decoction in patients with AP. E thics and dissemination: Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Chongqing Traditional Chinese Medicine University (Ethical Review Number:2023-ky-51). The results of this study will be published in a peer-reviewed journal. The study sponsor does not have any role in study-related activities or in the final publication of the study. T rial Registration: This trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).Registration number: ChiCTR2300076885, Date: 2020-10-23, version 1.1.