Abstract
INTRODUCTION: Diarrhea is a common complication in patients after cholecystectomy. In China, tens of millions of patients experience diarrhea every year after cholecystectomy, which results in long-term pain in patients. Traditional Chinese medicine is a national treasure and has made great contributions to human health throughout the long history of the Chinese nation. However, as a classic ready-for-use traditional Chinese medicine, the exact clinical efficacy of the Xianglian preparation needs further observation. This article presents the protocol of a single-center, randomized controlled trial to evaluate the clinical efficacy of Xianglian capsules in patients with diarrhea after cholecystectomy. METHODS AND ANALYSIS: This study was conducted in the Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital of Guangdong Medical University, following the recommendations of the current SPIRIT and CONSORT statements. We will recruit 90 patients who have developed diarrhea after cholecystectomy and randomize them 1:1 into the observation and control groups. The control group was given starch placebo capsules, and the observation group was given Xianglian capsules. Patient diarrhea-related indicators were collected at baseline and 5 days postdose. We will also collect patients' intestinal inflammation-related indicators and fecal microbial samples to analyze the possible mechanism of action of drugs. DISCUSSION: This study will clarify the clinical effects of the Xianglian preparation on patients with diarrhea after cholecystectomy, provide evidence-based evidence, and promote the development and application of this classic prescription. TRIAL REGISTRATION: http://www.chictr.org.cn . TRIAL NUMBER: ChiCTR2200061854. Registered on 04 July 2022.