枳术宽中胶囊治疗餐后不适综合征功能性消化不良的多中心随机双盲安慰剂平行对照临床研究方案。
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.
机构信息
NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine and National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
出版信息
Trials. 2022 Jun 2;23(1):454. doi: 10.1186/s13063-022-06396-5.
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.
背景
功能性消化不良（FD）是最常见的功能性胃肠疾病之一。根据餐后不适综合征（FD-PDS）患者的各种症状，常规药物如抑酸剂、促动力药和中枢作用药物的治疗选择有限，且可能有副作用。由于初步临床试验表明市售产品枳术宽中胶囊（ZZKZ）可改善 FD-PDS 患者的症状，本研究旨在为 ZZKZ 治疗 FD-PDS 患者的临床疗效和安全性提供进一步证据。
方法
这是一项多中心、随机、患者和研究者双盲、安慰剂对照、平行分组的临床试验，我们将从中国和澳大利亚的 18 家医院招募 FD-PDS 患者。试验将根据罗马 IV 诊断标准纳入 FD-PDS 患者。共有 480 名符合条件的患者将以 1:1 的比例随机分为 ZZKZ 或安慰剂组，治疗 8 周，随访 4 周。主要终点将通过患者自评视觉模拟评分（VAS）测量，评估餐后饱胀和早饱症状的不适程度，每天记录一次，每周记录 7 天。主要分析旨在比较治疗 8 周前后两组 FD-PDS VAS 评分的缓解率，组间差异以双侧检验的α水平 0.05 为界。
讨论
本试验旨在加强市售产品 ZZKZ 治疗 FD-PDS 的疗效和安全性证据。与之前针对 FD-PDS 的临床试验相比，本试验将有 8 周的双盲治疗期，通过与安慰剂组比较来研究长期药物治疗的效果。
试验注册
ClinicalTrials.gov NCT03825692。于 2019 年 1 月 28 日注册。
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