Efficacy and safety of Clidinium bromide and Chlordiazepoxide hydrochloride combination as add-on therapy in functional dyspepsia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20171016004

Enrollment

Registered

2017-10-16

Start date

2017-06-01

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 Clidinium bromide Chlordiazepoxide hydrochloride

Interventions

1 capsule consist of of Clidinium bromide 2.5 mg and Chlordiazepoxide hydrochloride 5 mg. Take 1 capsule 3 times/day before meal &#44

for 4 weeks,Take 1 placebo capsule 3 times/day before meal &#44

for 4 weeks

Experimental Drug,Placebo Comparator Drug

Clidinium bromide and Chlordiazepoxide hydrochloride combination,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients age 18-70 years Diagnosed functional dyspepsia according to Rome IV criteria Normal upper endoscopy within 1 year No evidence of Helicobacter pylori infection Partial or non-rensponder to proton pump inhibitor standard treatment

Exclusion criteria

Exclusion criteria: History of irritable bowel syndrome Major physical illness Current active alcohol abuse History of obstructive uropathy Pregnancy and Lactation History of allergy to benzodiazepine, proton pump inhibitor, antispasmodic and anticholinergic drug.

Design outcomes

Primary

Measure	Time frame
Global overall symptom scale Day 0 (at baseline), End of week 1, End of week 2, End of week 3 , End of week 4 score	—

Secondary

Measure	Time frame
Short form Nepean dyspepsia index Day 0 (at baseline), End of week 4 score	—

Countries

Thailand

Contacts

Public ContactSiripa Puasripun

Department of Internal Medicine, Faculty of medicine, Chiang Mai university

siripapuasripun@gmail.com0882683435

Outcome results

None listed

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

Efficacy and safety of Clidinium bromide and Chlordiazepoxide hydrochloride combination as add&#45;on therapy in functional dyspepsia