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Efficacy of Mirtazapine in patients with functional dyspepsia in a self-controlled clinical trial

Efficacy of Mirtazapine in patients with functional dyspepsia in a self-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048304
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

functional dyspepsia

Interventions

Sponsors

Zibo Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: According to the Rome IV functional gastrointestinal disease criteria, it is defined as: 1.Meet one or more of the following criteria: (1)Fullness and discomfort after a meal; (2)Early satiety; (3)Upper abdominal pain; (4)Upper Burning sensation in the abdomen. 2.There is no evidence of structural disease (including gastroscopy) that can explain the above symptoms (the symptoms appear at least 6 months before the diagnosis, and the above diagnostic criteria are met for the past 3 months). According to the characteristics of its symptoms, it is divided into two subtypes: postprandial discomfort syndrome (PDS) and epigastric pain syndrome (EPS). Select patients (aged 18 to 70 years) who meet the Rome IV FD diagnostic criteria in our hospital and have been treated with proton pump inhibitors, digestive enzymes, and kinetic drugs for 2 weeks in our hospital, and their total score for dyspepsia symptoms has decreased by <30%.

Exclusion criteria

Exclusion criteria: 1.Other mental illnesses, serious physical diseases; 2.Participants in other clinical trials within the past 3 months; 3.Women during pregnancy or breastfeeding; 45.Patients considered by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Total points for dyspepsia symptoms;Postprandial fullness;Upper abdominal bloating;Early satiation;

Secondary

MeasureTime frame
Nausea;Vomiting;Belching;Epigastric pain;Epigastric burning;Gastrointestinal-specific anxiety;Short Form-Nepean Dyspepsia Index;Body weight;

Countries

China

Contacts

Public ContactLi Gaozhong

Zibo Central Hospital

ligaozhong05@163.com+86 18678186361

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026