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To compare safety and efficacy of pantoprazole with pantoprazole plus amitriptyline in patients of functional dyspepsia.

To compare the safety and efficacy of pantoprazole with pantoprazole plus amitriptyline in functional dyspepsia patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055175
Enrollment
60
Registered
2023-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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 Health Condition 2: K297- Gastritis, unspecified Health Condition 3: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention1: Single Drug Regimen: Tab Pantoprazole 40mg BBF 30 minutes before breakfast per oral for 4 weeks Intervention2: Dual drug regimen: Tab Pantoprazole 40mg 30minutes before breakfast per or

Sponsors

Dr Rajendra Prasad Government Medical College Tanda at kangra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Functional dyspepsia patients ( no evidence of any structural disease likely to explain the symptoms including upper gastrointestinal endoscopy)

Exclusion criteria

Exclusion criteria: 1) Patients Not willing to give written informed consent . 2) Pregnant females. 3) Lactating females. 4) Active alcohol users. 5) Patients allergic or with known contraindications to any of study drugs. 6) Patients who are known case of cirrhosis ,chronic kidney disease, chronic heart disease,glaucoma , history of seizure , retention of urine . 7) use of similar drugs during last 2 weeks.

Design outcomes

Primary

MeasureTime frame
Improvement in Glasgow dyspepsia severity score,short form Leeds dyspepsia questionnaire and visual analogue scale in functional dyspepsia patientsTimepoint: After 4 weeks of enrollment

Secondary

MeasureTime frame
To evaluate the safety of two drugsTimepoint: From the initiation of treatment to 4 weeks after initiation of treatment

Countries

India

Contacts

Public ContactDr Atal Sood

DR. Rajendra Prasad Government Medical College Kangra At Tanda

58neelamthakur@gmail.com8219272767

Outcome results

None listed

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