The Role of Neuromodulators in Refractory Functional Dyspepsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-12-30

Brief Summary

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The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia

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Detailed Description

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Functional dyspepsia (FD) is a prevalent disease combined with emotional disorders. Antidepressants are beneficial in the treatment of refractory FD, while for the long-term use of antidepressants, it could lead to withdrawal syndrome or other adverse events.

Refractory FD patients were unsatisfied with the regular first-line anti-acid treatment. However, many patients were worried about taking antidiepressants, even though guideline has recommended antidepressant use in FD. In our study, we would use low-dose and short-term antidepressant in refractory FD patients, and investigate whether short-term antidepressants application would improve therapeutic efficacy and minimize antidepressant withdrawal of FD patients.

Conditions

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Dyspepsia Functional Gastrointestinal Disorders Antidepressant Discontinuation Syndrome Antidepressant Drug Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2-week group

Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand.

Group Type EXPERIMENTAL

Deanxit

Intervention Type DRUG

Central neuromodulators was applied in refractory FD patients for different time

4-week group

Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).

Group Type EXPERIMENTAL

Deanxit

Intervention Type DRUG

Central neuromodulators was applied in refractory FD patients for different time

Interventions

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Deanxit

Central neuromodulators was applied in refractory FD patients for different time

Intervention Type DRUG

Other Intervention Names

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Flupentixol and Melitracen

Eligibility Criteria

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Inclusion Criteria

* 18-70 years old;
* education level higher than middle school;
* met the Rome IV criteria for FD; absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
* absence of Helicobacter pylori infection;
* signed written informed consent for participation in the study.

Exclusion Criteria

* evidence of organic digestive diseases;
* diabetes, cancer and other diseases might affect GI function;
* pregnancy, lactation or breastfeeding;
* a history of allergic reaction to any of the drugs used in the study;
* participation in other clinical trials in the previous 3 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No