Zhizhu Kuanzhong Capsule in treating patients with functional dyspepsia postprandial distress syndrome: study protocol for a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial

Autor: Mengli Xiao, Linda L. D. Zhong, Wai Ching Lam, Yingpan Zhao, Kok-Ann Gwee, Gerald Holtmann, Jan Tack, Hidekazu Suzuki, Min-Hu Chen, Yinglian Xiao, Xiaohua Hou, Jinsong Liu, Yang Li, Xu-Dong Tang, Fang Lu
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Trials, Vol 23, Iss 1, Pp 1-10 (2022)
Druh dokumentu: article
ISSN: 1745-6215
64912434
DOI: 10.1186/s13063-022-06396-5
Popis: Abstract Background Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Based on the various symptoms present in patients with functional dyspepsia postprandial distress syndrome (FD-PDS), routine agents such as acid suppressants, prokinetic drugs, and centrally acting drugs, offer limited treatment choices with potential side effects. As a preliminary clinical trial showed that the marketed product Zhizhu Kuanzhong Capsule (ZZKZ) can improve symptoms in FD-PDS patients, our study aims to provide further evidence on the clinical efficacy and safety of ZZKZ in the treatment of patients with FD-PDS. Methods In this multicenter, randomized, patient- and investigator-blinded, placebo-controlled, parallel-group clinical trial, we will recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial will enroll patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients will be randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint will be measured by a self-rated Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early satiation, recorded once a day and 7 days a week. The primary analysis will aim to compare the response rate for FD-PDS VAS score between the groups before and after 8 weeks of treatment with an alpha level of 0.05 (2-sided). Discussion This trial aims to strengthen the evidence for the efficacy and safety of ZZKZ, a marketed product, in treating FD-PDS. Compared to the previous clinical trial that targeted FD-PDS, this trial will have an 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group. Trial registration ClinicalTrials.gov NCT03825692 . Registered on 28 January 2019
Databáze: Directory of Open Access Journals
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