Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia

Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia - Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for Functional Dyspepsia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003954

Enrollment

430

Registered

2010-07-27

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Functional Dyspepsia

Interventions

traditional Chinese medicine placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with functional dyspepsia diagnosed according to the Rome three classification 2. Patients with dyspeptic symptom by symptomatic scale 3 points or more, for over four days, for two weeks before registration 3.Patients have average 4 points or more by abdominal pain domain or dyspepsia domain of GSRS, or patients have 5 points or more, at one more items of abdominal pain domain or dyspepsia domain of GSRS 4.Patients aged 20 or older 5.regardless of sex 6.regardless of admission to hospital 7.Patients whose written informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1. Patient with Organic disease such as reflux esophagitis (> grade A) and erosive gastritis. 2. Patients with past history of upper gastrointestinal surgery 3. Patients with past history of gastrectomy 4.Patients with an obvious cause of symptom 5. NSAIDs or low-dose aspirin -related dyspepsia 6. Patients with organic disease in the brain or with psychological disorders 7. Patients with alcoholics or with drug dependence 8. Severe endocrine disease including hyperthyroidism 9. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases 10. Drug allegy for Rikkunshito 11.Expectant mother, mother with breast-feeding, or females who wish to become pregnant 12.Patient with H.pylori eradication within 6 months 13.Patients who take gastric secretion inhibitor, prokinetic agent, gastric antacid, anticholineric drug, cholinergic agent, tranquilizer, anxiolytic agent drug, antidepressive drug within 1 week 14. Patients with suspected IBS 15. other not applicable person recognized by a doctor

Design outcomes

Primary

Measure	Time frame
Improvement rate of global patient assessment at 8 weeks after initial treatment	—

Secondary

Measure	Time frame
1.Rate of Gastrointestinal Symptom Rating Scale(GSRS) after treatment 2.Improvement rate of dyspeptic symptoms by symptomatic scale	—

Countries

Japan

Contacts

Public ContactNaoki Tomotsugu, Ph.D.

Keio University School of Medicine Center for Clinical Research

03-5363-3288

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026