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Low-dose amitriptyline in uninvestigated dyspepsia: a pragmatic open-label cluster randomized controlled trial

Low-dose amitriptyline in uninvestigated dyspepsia: a pragmatic open-label cluster randomized controlled trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201218006
Enrollment
40
Registered
2020-12-18
Start date
2020-11-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia is a gastrointestinal disorder that is found in up to 20 percent of the world&#39

Interventions

Patients received amitriptyline 10 mg daily plus omeprazole 20 mg daily for 8 weeks.,Patients received omeprazole 20 mg daily.
Experimental Drug,Active Comparator Drug
Low dose amitriptyline with PPIs,PPIs only

Sponsors

Nantikarn Yingrattanasuk
Lead Sponsor
Roi Et Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with functional dyspepsia as defined by Rome IV criteria who have not had an endoscopy (uninvestigated dyspepsia). 2. No history of taking the following drugs for at least 1 week: proton pump inhibitor, antacid, H2antagonist, prokinetic, antispasmodic, carminative.

Exclusion criteria

Exclusion criteria: 1. Have a history of hypersensitivity to Amitriptyline and / PPIs, or have a history of pregnancy or breastfeeding. 2. Have gastric malignancy, cardiac arrhythmia, congestive heart failure, untreated glaucoma, benign prostate hypertrophy, uncontrolled diabetes. 3. Have a history of using drug groups Antidepressant, Benzodiazepine, NSAIDs including fluoxetine, citalopram, fluvoxamine, sertraline, escitalopram, paroxetine, nortriptyline, mirtazapine, trazodon, chlordiazepoxide, clonazepam, clorazepate, clobazam, diazepam, flurazepam, lorazepam, midazolam, prazepam,triazolam, ibuprofen, naproxen, diclofenac, mefenamic acid, indomethacin and aspirin.

Design outcomes

Primary

MeasureTime frame
Global overall symptom scale of dyspepsia 8 weeks self assessment

Secondary

MeasureTime frame
Global overall symptom scale of dyspepsia 8 weeks self assessment report

Countries

Thailand

Contacts

Public ContactNantikarn Yingrattanasuk

Department of social medicine, Khon kaen hospital

nantikarn.y@kkumail.com+66804149596

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026