Efficacy of DaXianXiong Decoction in Preventing the Progression of Acute Pancreatitis Severity: Protocol for a Randomized Controlled Trial.

Abstract

Background: Low- and middle-income 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 AP (SAP) results in a series of complications such as organ dysfunction, local abscesses, pseudocysts, and necrosis. Although the treatment of AP is primarily supportive, including fluid resuscitation and organ support, there is still a lack of consensus on the optimal management regimen for fluid therapy, and strategies to promote gastrointestinal recovery remain limited. As no effective intervention measure has yet been developed, supportive therapy remains the primary approach for the early treatment of AP. DaXianXiong decoction is a widely used traditional Chinese medicine formulation; however, limited research has been conducted on its clinical efficacy.

Objective: This study aims to evaluate the efficacy and safety of DaXianXiong decoction in preventing AP from progressing to SAP, assessing its impact on SAP incidence, clinical severity scores, inflammation markers, and gastrointestinal function, and providing evidence for AP management.

Methods: This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. The primary outcomes will include the incidence of SAP, modified computed tomography severity index score, APACHE II (Acute Physiology and Chronic Health Evaluation 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 hours after the intervention; and on days 3, 7, and 28 after the intervention in both groups. A total of 60 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. The intervention group will additionally receive DaXianXiong decoction, while the control group will receive a placebo similar to the decoction.

Results: This study has been funded by the Performance Incentive Project of Scientific Research Institutions in Chongqing. The trial was registered in April 2024, and data analysis is expected to be completed by April 2025. The study results will be presented at both national and international conferences and published in peer-reviewed journals.

Conclusions: This trial will help us assess the effectiveness and safety of DaXianXiong decoction in patients with AP and provide clinical evidence on the efficacy and safety of DaXianXiong decoction in preventing the progression of AP to SAP. By evaluating its impact, the findings will contribute to the understanding of DaXianXiong decoction as an adjunct therapy in AP management and may offer a novel complementary treatment strategy for AP, potentially improving patient outcomes and reducing complications.

Trial registration: Chinese Clinical Trial Registry ChiCTR2300076885; https://www.chictr.org.cn/showproj.html?proj=207084.

International registered report identifier (irrid): DERR1-10.2196/67392.