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Comparison of effect of Vonoprazan with Esomeprazole in Functional Dyspepsia patient by suitable research method

Study Of Efficacy of Vonoprazan Versus Esomeprazole in Functional Dyspepsia in A Tertiary Care Hospital: A Single Blinded Randomized Comparative Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089225
Enrollment
132
Registered
2025-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K30- Functional dyspepsia

Interventions

Intervention1: Vonoprazan: Tab Vonoprazan 20mg once a day for 4 weeks Control Intervention1: Esomeprazole: Tab Esomeprazole 40 mg once a day for 4 weeks

Sponsors

IMS SUM Hospital SOA university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: APatient with diagnosis of Functional dyspepsia as per ROME IV CRITERIA Age more thsn 18 years of both sex Not taken any other drugs for the Dyspepsia symptoms for last 2 weeks before the date of diagnosis

Exclusion criteria

Exclusion criteria: Patient unwilling to give consent Pregnancy, Lactating women Patient with H. pylori infection detected by Urease test Peptic ulcer disease Anxiety and Depression unrelated to Dyspepsia Patient taking Anti-psychotics Chronic lung ,liver and kidney disease Cancer Cardiac co-morbidities Active Alcoholism

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of vonoprazan 20 mg and esomeprazole 40 mg which will be assessed by Global overall symptom scale(GOSS) 2.Improvement in quality-of-life evaluation by Nepean dyspepsia index 3.Mental health status using Hospital Anxiety and Depression Scale(HADS)Timepoint: 0 week, 4 weeks , 6weeks of drug administrated

Secondary

MeasureTime frame
To Assess the adverse effects of the drugsTimepoint: 4 weeks, 6 weeks of drug administration

Countries

India

Contacts

Public ContactDr Snigdha Sucharita

IMS and SUM Hospital Bhubaneswar

smita.das@soa.ac.in9438418397

Outcome results

None listed

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