Could old drugs ease mysterious stomach pain?
NCT ID NCT07008235
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether two medications, amitriptyline and trifluoperazine, can reduce stomach symptoms in people with functional dyspepsia—a condition where the stomach feels upset without a clear cause. About 120 adults will take one of the drugs or stick with standard treatment for 8 weeks, then be monitored for 4 more weeks. Researchers will track symptom changes and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amitriptyline and trifluoperazine
- What this could lead to
- If successful, this could point toward a new treatment option for people with functional dyspepsia who don't get enough relief from standard care.
- What could go wrong
- This is a mid-stage trial with only 120 participants, so results may not apply to everyone. Both drugs can cause side effects like drowsiness or dizziness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or more * Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria * Patients who are willing to sign informed written consent Exclusion Criteria: * Structural lesion in Upper GI endoscopy and/or positive CLO test * Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms * History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders * Previous history of gastrointestinal surgery * Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine * Any patient with ongoing treatment with antidepressants or antipsychotics * Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine * Patients for whom Amitriptyline and Trifluoperazine are contraindicated * Elderly patients\> 60 years * Pregnancy and breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dhaka Medical College
RECRUITINGDhaka, 1000, Bangladesh
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