TY - JOUR
T1 - Zhizhu Kuanzhong Capsule in treating patients with functional dyspepsia postprandial distress syndrome
T2 - study protocol for a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial
AU - Xiao, Mengli
AU - Zhong, Linda L. D.
AU - Lam, Wai Ching
AU - Zhao, Yingpan
AU - Gwee, Kok Ann
AU - Holtmann, Gerald
AU - Tack, Jan
AU - Suzuki, Hidekazu
AU - Chen, Min Hu
AU - Xiao, Yinglian
AU - Hou, Xiaohua
AU - Liu, Jinsong
AU - Li, Yang
AU - Tang, Xu Dong
AU - Lu, Fang
N1 - Funding Information:
The study is supported by Special Research on Modernization of Traditional Chinese Medicine in the National Key Research and Development Program in China’s 13th Five-Year Plan Demonstrative Research on TCM-related International Cooperation with Countries along the Belt and Road (No.2017YFC1703703). The funding plays no role in the study design, collection, management, analysis, interpretation of data, writing of the report, or decision to submit the report for publication.
Publisher Copyright:
© The Author(s) 2022.
PY - 2022/6/2
Y1 - 2022/6/2
N2 - 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.
AB - 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.
KW - Functional dyspepsia
KW - Postprandial distress syndrome
KW - Randomized controlled trial
KW - Zhizhu Kuanzhong
UR - https://www.scopus.com/pages/publications/85131134641
U2 - 10.1186/s13063-022-06396-5
DO - 10.1186/s13063-022-06396-5
M3 - Journal article
C2 - 35655286
AN - SCOPUS:85131134641
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 454
ER -