Investigation of the usefulness of Rikkunshi-to in functional dyspepsi

JRCT ID: jRCT1061220076

Registered date:23/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Functional Dyspepsia
• Date of first enrollment: 23/12/2022
• Target sample size: 90
• Study type: Interventional

Intervention(s)

PPI (esomeprazole 10mg/day) monotherapy group
Starting from the date of diagnosis, esomeprazole 10 mg/day will be administered once daily for 56 days as a single agent.
No other supportive care such as other gastrointestinal drugs will be administered.
As a rule, administration of prohibited drugs is not allowed.

PPI (esomeprazole 10 mg/day) + Rikkunshi-to (7.5 g/day) group
From the date of diagnosis, esomeprazole 10 mg/day once a day + Rikkunshi-to (7.5 g/day) one packet before each meal for 56 days.
No other supportive care such as other gastrointestinal drugs will be administered.
As a rule, administration of prohibited drugs is not allowed.

Outcome(s)

• Primary Outcome: Scoring by mFSSG, GSRS, and VRS before and 2 weeks after treatment to examine improvement of symptoms in the early stages.

Secondary Outcome

(1) Scoring by mFSSG, GSRS, and VRST at 4 and 8 weeks to examine improvement of symptoms over time.
(2) Presence or absence of adverse events of the drug

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

All of the following are required
1) At least one symptom of dyspepsia on the mFSSG questionnaire
2) Helicobacter pylori (HP) negative or after HP eradication
3) 20 years of age or older
4) Patients must have one of the following symptoms: postprandial complaint syndrome (lethargy and early satiety after eating) or epigastric pain syndrome (epigastric pain and burning sensation in the epigastrium).

Exclude criteria

Persons who fall into any of the following categories are excluded
1) Patients with current HP infection
2) Patients with organic disease on upper gastrointestinal endoscopy
3) Patients who have already started medical treatment for the same symptoms
4) Patients taking NSAIDs (non-steroidal anti-inflammatory drugs)
5) Patients with a history of allergy to the drugs to be used
6) Patients deemed inappropriate by the investigator

Related Information

• Primary Sponsor: Yachida Tatsuo