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NOT YET RECRUITING
NCT06931223
NA

Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-04-10

Completion Date

2025-09-10

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DRUG

Flupentixol-Melitracen + Lansoprazole

Flupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia.

DRUG

Lansoprazole

Placebo and Lansoprazole for functional dyspepsia.