Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 10, 2024
Date Accepted: Mar 17, 2025
Date Submitted to PubMed: Mar 18, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of DaXianXiong decoction in preventing the progression of severity of acute pancreatitis: Study protocol for a randomized controlled trial
ABSTRACT
Background:
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.
Objective:
we propose a standardized clinical trial to evaluate the effectiveness and safety of DaXianXiong decoction in preventing the progression of AP to SAP.
Methods:
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.
Results:
This trial will help us assess the effectiveness and safety of DaXianXiong decoction in patients with AP.
Conclusions:
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. Clinical Trial: This trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).Registration number: ChiCTR2300076885, Date: 2023-10-23, version 1.1.
Citation
The author of this paper has made a PDF available, but requires the user to login, or create an account.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.