Efficacy of unripe banana powder with ginger extract versus unripe banana powder only versus placebo in treatment of functional dyspepsia. A Multicenter Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250822002

Enrollment

Registered

2025-08-22

Start date

2024-07-01

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

Dyspepsia1,2 refers to pain, cramps, tightness, burning, and discomfort in the upper abdomen, indicating abnormalities in the upper gastrointestinal tract. Symptoms must last for at least 4 weeks and may include other symptoms such as flatulence, nausea, burping, or heartburn, but there must be no warning signs (Alarm Symptoms) such as gastrointestinal bleeding, anemia, poor appetite, unintentional weight loss of more than 5 percent in 1 month or 10 percent in 6 months, and a history of stomach

Interventions

Unripe banana Drug,Unripe banana with ginger extract,Placebo

Experimental Drug,Active Comparator Drug,Placebo Comparator Drug

Unripe banana,Unripe banana with ginger extract,Placebo

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 20-80 years 2.Adults diagnosed with functional dyspepsia according to the ROME IV Criteria, with upper gastrointestinal endoscopy results showing no ulcers or lesions in the stomach 3.Patients consented to participate in the research.

Exclusion criteria

Exclusion criteria: 1 There is a pathology that can explain the patient's symptoms from the endoscopy of the upper gastrointestinal tract. 2 Helicobacter pylori infection detected 3 The patient has acute gastrointestinal bleeding such as black stool, vomiting blood. 4 The patient has paleness (Hb < 10 g/dL) 5 The patient lost more than 5 percent of weight in 1 month or 10 percent in 6 months. 6 The patient has a history of direct relatives with stomach cancer. 7 The patient has jaundice Total bilirubin > 2mg/dL 8 Patients with chronic renal failure stage 4 onwards (eGFR < 30 ml/min/1.73m2) 9 The patient has a history of using NSAIDs, ASA or other antiplatelet drugs within 4 weeks. 10 Pregnant or planning to become pregnant 11 Patients with a history of banana allergy, banana powder

Design outcomes

Primary

Measure	Time frame
Efficacy 1 month after intervention SODA (Severity of dyspepsia assessment)score and EQ5D (EuroQul 5 level)score	—

Secondary

Measure	Time frame
Safety 1 month after intervention EQ5D score (EuroQol 5 level)	—

Countries

Thailand

Contacts

Public ContactSuntipop Kongsala

Department of medicine

Mr.new230@gmail.com0841224071

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026