The exploratory analysis for the efficacy and safety of Rikkunshito for upper gastrointestinal symptoms in the patients with functional dyspepsia

UMIN ID: UMIN000001922

Registered date:01/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Functional dyspepsia
• Date of first enrollment: 2008/03/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Rikkunshito 7.5g per day before meal 4 weeks
Domperidone 30mg per day before meal 4 weeks

Outcome(s)

• Primary Outcome: The upper gastrointestinal symptoms at 2 and 4 weeks after drug administartion
• Secondary Outcome: The change of the level in the hormone related to appetite at 2 and 4 weeks after drug administartion

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: The patients (1)after removal of their stomach (2)with heart failure or severe inflammation (3)with disorder in liver, gallbladder, or pancreas (4)with pregnancy, or breast-feeding now (5)with astrointestinal bleeding, mechanical ileus, perforation in gastrointestine (6)taking prohibited drug during trial (7) impossible to take a drug per oral (8)taking herbal medicine during trial (9)who are unsuitable judged by the responsible person

Related Information

• Primary Sponsor: Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University
• Source(s) of Monetary Support: TSUMURA Co.