Effectiveness and safety of Pinaverium Bromide as an add-on therapy in functional dyspepsia, a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210819002

Enrollment

Registered

2021-08-19

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Functional dyspepsia Functional dyspepsia Pinaverium Bromide Efficacy and safety

Interventions

Pinaverium bromide 50 mg 1 capsule Route : oral Duration : 3 times daily for 8 weeks,Placebo drug 1 capsule Route : oral Duration : 3 times daily for 8 weeks

Active Comparator Drug,Placebo Comparator Drug

Pinaverium Bromide,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 year-old 2. Diagnosed functional dyspepsia according to ROME IV criteria 3. Normal EGD findings, up to 3 years prior to enrollment 4. No evidence of Helicobacter Pylori infection 5. Not or partial response to standard dose PPI for 8 weeks

Exclusion criteria

Exclusion criteria: 1. Predominate symptoms of GERD and bowel dysmotility symptoms 2. Allergic to proton pump inhibitor 3. Severe psychological disorders 4. currently pregnant of planned pregnant or breast feeding 5. Currently use of NSAIDs

Design outcomes

Primary

Measure	Time frame
Self report outcome of satisfaction At the end of intervention (8 weeks) Self report outcome	—

Secondary

Measure	Time frame
Global overall symptoms score At 0, 4, and 8 week of intervention Global overall symptoms score	—

Countries

Thailand

Contacts

Public ContactThansita Kamolsripat

Chiangmai University

am_natnicha@hotmail.com0840209247

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026