scholarly journals Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study

Cureus ◽  
2021 ◽  
Author(s):  
Shubhadeep D Sinha ◽  
Saroj K Sinha ◽  
Leela Talluri ◽  
Ramesh K Bhashyakarla ◽  
Umadevi Malladi ◽  
...  
Keyword(s):  
Functional Dyspepsia ◽  
Multicenter Study ◽  
Extended Release ◽  
Distress Syndrome ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Postprandial Distress Syndrome

scholarly journals 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

2021 ◽  
Author(s):  
Mengli Xiao ◽  
Linda LD Zhong ◽  
Wai Ching Lam ◽  
Yingpan Zhao ◽  
Kok-Ann Gwee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Functional Dyspepsia ◽  
Distress Syndrome ◽  
Functional Gastrointestinal Disorders ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Postprandial Distress Syndrome ◽  
Parallel Group

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 choice with potential side effects. As 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, double-blind, placebo-controlled, parallel group clinical trial, we recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial enrolls patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients are randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint is measured by 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 aims 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 previous clinical trial targeted FD-PDS, this trial has 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group.Trial registration: This study is registered with ClinicalTrials.gov on 28 January 2019, number NCT03825692.

383 - The Therapeutic Outcome of Itopride in Functional Dyspepsia Postprandial Distress Syndrome: A Double-Blind Randomized, Multicenter, Placebo-Controlled Study

2018 ◽  
Vol 154 (6) ◽  
pp. S-91 ◽  
Author(s):  
Florencia Carbone ◽  
Alain Vandenberghe ◽  
Lieselot Holvoet ◽  
Tim Vanuytsel ◽  
Michael P. Jones ◽  
...  
Keyword(s):  
Functional Dyspepsia ◽  
Distress Syndrome ◽  
Therapeutic Outcome ◽  
Controlled Study ◽  
Double Blind ◽  
Postprandial Distress Syndrome
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