Efficacy and Safety of Curcumin-Chitosan Compared with Omeprazole in Functional Dyspepsia: A Randomized, Double-Blind, Non-Inferiority, Placebo-Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241012014

Enrollment

146

Registered

2024-10-12

Start date

2024-06-17

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 curcumin functional dyspepsia microbiota chitosan

Interventions

Curcumin-chitosan group (bid) plus, placebo of omeprazole (od) ,Omeprazole (20 mg) group (od) plus, placebo of curcumin-chitosan (bid)

Experimental Drug,Active Comparator Drug

Curcumin-chitosan group,Omeprazole (20 mg) group

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients age 18-80 years Diagnosed with FD according to Rome IV criteria and have normal EGD (no esophagitis, Barrett's esophagus, cancer, erosions, or ulcer disease) and H.pylori negative within the past 5 years

Exclusion criteria

Exclusion criteria: Predominant symptoms of GERD or IBS History of gastric surgery or gastric bypass surgery Patient with inflammatory bowel disease Patient with active cancer (cancer not remission in the past six months) Patient with an active psychiatric condition Alcohol use of more than ten units per week Use of immunosuppressant drugs, antibiotics, or probiotics in the past four weeks Use of nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or other antiplatelet or anticoagulants in the past four weeks Laboratory abnormality including total serum bilirubin more than 2 mg/dL, hemoglobin less than 10 gm/dL, eGFR less than 30 ml/min/1.73 m2 Pregnancy or lactation History of allergy to curcumin, chitosan or omeprazole History of allergy to rich-chitosan food such as shrimp, crab, squid, shellfish, mushroom Patient will have a plan for any surgery in 8 weeks after including to research study. Not sign inform consent

Design outcomes

Primary

Measure	Time frame
Change in FD symptoms 8 weeks SODA score	—

Secondary

Measure	Time frame
health-related quality of life 8 weeks PAGI-QOL, EuroQol-5 Dimension 5 Level (EQ-5D-5L) questionnaire and EuroQol Visual Analog Scale (EQ-VAS),safety 8 weeks Report symptoms,Change in fecal microbiota 8 weeks fecal microbiota,inflammatory markers, systemic cytokines, and gut-associated markers 8 weeks inflammatory markers, systemic cytokines, and gut-associated markers	—

Countries

Thailand

Contacts

Public ContactApichat Kaewdech

Prince of Songkla University

immilkku@gmail.com0828013379

Outcome results

None listed

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