An interventional study of Flupentixol-Melitracen + Lansoprazole and Lansoprazole in Functioanl Dyspepsia, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 200 is above the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Flupentixol-Melitracen + Lansoprazole
Drug: Lansoprazole
Flupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia.
Placebo and Lansoprazole for functional dyspepsia.
Leuven Postprandial Distress Scale (LPDS) score
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.
Time frame: Until the end of the study, up to 14 weeks
No study locations are listed for this record.
Start is estimated for Apr 2025; primary completion for Sep 2025, 5 months later.
Of 71 non-industry interventional studies with no phase under Dyspepsia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 5 months is below that.
Counting every sponsor, half of 79 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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