NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001922

Registered date:01/05/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedFunctional dyspepsia
Date of first enrollment2008/03/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Rikkunshito 7.5g per day before meal 4 weeks Domperidone 30mg per day before meal 4 weeks

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteriaThe patients diagnosed as functional dyspepsia by the Rome III criteria
Exclude criteriaThe 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

Contact

public contact
Name MAKOTO ARAI
Address Inohana 1-8-1, Chuo-ku, Chiba-City, Japan Japan
Telephone
E-mail
Affiliation Graduate School of Medicine, Medicine and Clinical Oncology
scientific contact
Name MAKOTO ARAI
Address Inohana 1-8-1, Chuo-ku, Chiba-City, Japan Japan
Telephone 043-226-2083
E-mail
Affiliation Graduate School of Medicine, Chiba University Medicine and Clinical Oncology