This study is a double-blinded Randomised clinical trial aim to compare buspirone plus omeprazole with placebo plus omeprazole.
Full Title of Study: “Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Care Provider)
- Study Primary Completion Date: March 1, 2017
- Drug: Buspirone
- Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.
- Drug: Placebo Oral Tablet
- Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.
Arms, Groups and Cohorts
- Experimental: Buspirone plus Omeprazole
- Placebo Comparator: Placebo plus Omeprazole
Clinical Trial Outcome Measures
- 70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo
- Time Frame: 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe
- Global symptom measured through a checklist of dyspepsia symptoms at first visit and four weeks after
Participating in This Clinical Trial
- being over 18-year-old, Rome III criteria for FD
- normal upper endoscopy within five years
- negative Urease test for H-pylori
- acceptance informed concept form.
- denied to get these medications
- taking other drugs for FD
- patients with the organic gastrointestinal disorder
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Isfahan University of Medical Sciences
- Provider of Information About this Clinical Study
- Principal Investigator: Meisam AbdarEsfahani, Mediacal Doctor – Isfahan University of Medical Sciences
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