NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001924

Registered date:01/05/2009

The exploratory analysis for the efficacy and safety of Rikkunshito for appetite loss during the treatment with PEG-interferon and ribavirin

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedThe patients with appetite loss during the treatment with PEG-interferon and ribavirin in the patients with hepatitis C
Date of first enrollment2008/01/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Rikkumshito 7.5g per day before meal 2 weeks Domperidone 30mg per day before meal 2 weeks

Outcome(s)

Primary OutcomeThe improvement of appetite loss at 1 and 2 weeks after drug administartion
Secondary OutcomeThe change of the level in the hormone related to appetite at 1 and 2 weeks after drug administartion

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteriaThe patients with appetite loss during the treatment with PEG-IFN+ribavirin
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
Address Japan
Telephone
E-mail
Affiliation Graduate School of Medicine, Chiba University Medicine and Clinical Oncology
scientific contact
Name MAKOTO ARAI
Address Inohana 1-8-1, Chuo-ku, Chiba City, JAPAN Japan
Telephone
E-mail
Affiliation Graduate School of Medicine, Chiba University Medicine and Clinical Oncology