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Investigation of the effectiveness of Buspirone and Mirtazapine on functional dyspepsia

Investigation of the effectiveness of anti-anxiety medication (Buspirone and Mirtazapine) on anxiety and gastrointestinal symptoms of functional dyspepsia patients with postprandial discomfort syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210724051972N1
Enrollment
120
Registered
2022-12-29
Start date
2021-11-01
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Functional dyspepsia. Functional dyspepsia,Mirtazapine,Buspirone,Anxiety

Interventions

Intervention 1: Intervention group: First - Buspirone receiving group with a dose of 5 mg three times a day for three months (Buspirax-brand name, Tehrandaroo factory). Intervention 2: Control group:

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study after explaining all the objectives of the research and the advantages and disadvantages of the methods Failure to receive psychological treatment before entering the study Lack of other structural or functional gastrointestinal disorders No other organic disease Possibility to keep the type and amount of drug used during the research period if the drug is used No alcohol and drugs No psychotic disorder and personality disorder Absence of alarm signs such as gastrointestinal bleeding, blood in the stool, fever, weight loss, anemia, nocturnal diarrhea, severe heartburn Age between 18 and 50 years

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The severity of dyspepsia symptoms in the three groups receiving buspirone, mirtazapine and the control group. Timepoint: The severity of dyspepsia symptoms in the three groups receiving buspirone, mirtazapine before the intervention and one month after the intervention and three months after the intervention and in the control group before the intervention and one month after the intervention. Method of measurement: patient assessment of upper gastrointestinal symptom severity index questionnaire(pagi-sym).;Beck anxiety score in three groups receiving buspirone, mirtazapine and control group. Timepoint: Determining and comparing the mean score of Beck anxiety in the two groups receiving buspirone, receiving mirtazapine before the intervention, one month after the intervention and three months after the intervention and in the control group before the intervention and one month after the intervention. Method of measurement: Beck Anxiety Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Tahmineh Tavakoli

Birjand University of Medical Sciences

tahminetavakoli93238@yahoo.com+98 56 3243 6200

Outcome results

None listed

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