Randomized controlled trial to determine the efficacy and safety of daikenchuto for abdominal pain and bloating sensation of IBS

UMIN ID: UMIN000001797

Registered date:25/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Irritable bowel syndrome
• Date of first enrollment: 2009/03/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral administration of Daikenchuto 15g/day b.i.d or t.i.d. before meals or between meals.
Oral administration of polycarbophil 1.5-3.0g/day t.i.d. after meals.

Outcome(s)

• Primary Outcome: IBS-QOL-J

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients who have bowel move disturbance by organic lesion such as IBD(UC and crohn disease etc.) and cancer. 2) Patients suspected of obstruction in stomach and intestines, and with a history of total gastric resection or bowel resection but not apendicitis 3) Patients with hypercalcemia, calculus in the kidney and dysfunction of kidneys. 4) Patients who are taking cardiac glycoside and tetracyclines antibiotics. 5) Patients who took antibiotics at least 2 month prior to observation period 6) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder) 7) Patients with a history of drug allergy 8) Patients who are nursing, pregnant or considering conception 9) Patients who are taking Kampo medicine. 10) Others, including patients who are unfit for the study as determined by the research director or others

Related Information

• Primary Sponsor: TJ-100 IBS study group
• Source(s) of Monetary Support: Tsumura & Co.