The exploratory study for the efficacy and safety of rikkunshito on anorexia in the patients who underwent laparoscopic assisted pylorus preserving gastrectomy

UMIN ID: UMIN000002295

Registered date:05/08/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Gastric cancer patient who underwent LAPPG
• Date of first enrollment: 2009/08/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral administration of rikkunshito (2.5g t.i.d) before or between meals for 77 days

Outcome(s)

• Primary Outcome: Improvement of anorexia and rate of body weight loss after LAPPG
• Secondary Outcome: Abdominal pain, dyspepsia and other gastrointestinal symptoms. Nutritional factor. Safety of rikkunshito

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients with multiple cancer 2)Patients who have nutritional disorder before surgery 3)Patients whose main organ function is not working 4)Patients who had administration of other Kampo medicine 1 month prior to the administration of test drug 5)Patients with severe cardiac failure, acute inflammatory disease or other severe complications 6)Patients who are intolerant to oral administration 7) Patients who are pregnant, considering pregnancy or lactation 8)Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation 9)Patients who has history of hypersensitivity toward Kampo medicine 10)Patients considered inappropriate by the study investigator

Related Information

• Primary Sponsor: The Cancer Institute Hospital of JFCR Gastroenterological Surgery
• Source(s) of Monetary Support: TSUMURA & CO.