The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy
Not Applicable
- Conditions
- Gastric cancer patient who underwent gastrectomy
- Registration Number
- JPRN-UMIN000010873
- Lead Sponsor
- The Cancer Institute Hospital of JFCR Gastroenterological Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have nutritional disorder before surgery 2) Patients who have another active malignancy 3) Patients with severe complications(ASA >=3 or PS>=2) 4) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation 5) Patients with mental disorder considered inappropriate by the study doctor 6) Patients with adjuvant chemotherapy after surgery 7) Patients receiving KAMPO medicine 8) Patients who has history of hypersensitivity to Kampo medicine 9) Patients who are pregnant, considering pregnancy or lactation 10) Patients considered inappropriate by the study investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) QOL score (ES3/EGQ, GSRS, SF-12) 2) body weight 3) body mass index 4) nutritional factor (Alb, Pre-Alb, TP, T-Cho, WBC, Lym)
- Secondary Outcome Measures
Name Time Method 1)AST,ALT, GGTP,ALP,T-Bil, RBC, Hb, Hct, CRP, Na, K, creatinine, BUN 2)adverse events 3)side effects