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临床试验/NCT06931223
NCT06931223尚未招募不适用

Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study

RenJi Hospital0 个研究点目标入组 200 人开始时间: 2025年4月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Leuven Postprandial Distress Scale (LPDS) score

研究概览

简要总结

The use of Neuromodulators is now recognized by international consensus as effective in improving Disorders of Gut-Brain Interaction (DGBIs). However, the digestive mind-body concept of therapeutic drugs is still in the experience-based treatment stage, and there is a lack of clinical studies in the field of DGBIs. Although numerous studies have been conducted to confirm the safety of Neuromodulators for the treatment of DGBIs, the current functional dyspepsia (FD) treatment is still awaiting further explorations and accumulations. In addition, neuromodulators, like Flupentixol-Melitracen (FM), are often used as a second-line treatment option for FD after the failure of acid-suppressive therapy with proton pump inhibitors, etc. However, the efficacy of conventional drugs for FD is mediocre, which often leads to recurrent and prolonged symptoms, seriously affecting patients' confidence in treatment and their quality of life, and the repeated visits to the clinic also create a huge economic burden for the society. Therefore, we conducted a clinical trial to verify whether FM can be used as the first-line therapy to improve the efficacy of FD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients with primary FD who meet the diagnostic criteria for Roman IV;
  • able to complete the questionnaire, trial evaluation and sign the written informed consent.

排除标准

  • organic gastrointestinal diseases by gastroenteroscopy within 6 months;
  • severe insufficiency of heart, liver, kidney, lung and other important organs and with congenital diseases;
  • allergic to the drugs used in this study
  • being pregnant, lactating or planning to become pregnant;
  • are taking or have taken monoamine oxidase inhibitors within the past 5 weeks;
  • have a known risk of narrow angle glaucoma.

研究组 & 干预措施

Patients were treated with Flupentixol-Melitracen (FM) plus lansoprazole for 2 weeks

Experimental

干预措施: Flupentixol-Melitracen + Lansoprazole (Drug)

Patients were treated with placebo plus lansoprazole for 2 weeks

Experimental

干预措施: Lansoprazole (Drug)

结局指标

主要结局

Leuven Postprandial Distress Scale (LPDS) score

时间窗: Until the end of the study, up to 14 weeks

The LPDS questionnaire contains 8 symptoms, namely early satiation, postprandial fullness, upper abdominal bloating, epigastric pain, epigastric burning, nausea, belching, and heartburn. Each symptom was rated on a severity scale of 0-4. The mean of the early satiation, postprandial fullness, and upper abdominal bloating scores was calculated as the postprandial distress syndrome score, and the mean of the epigastric pain, epigastric burning scores was calculated as the epigastric pain syndrome. Changes in LPDS score during the treatment period were assessed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shengliang Chen

Professor

RenJi Hospital

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