Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients: a multicenter randomized controlled trial
Phase 2
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000041840
- Lead Sponsor
- Department of Surgery, Nara Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients scheduled to preoperative chemotherapy and/or radiotherapy 2) Any Japanese herbal medicine within 4 weeks before the commencement of the study 3) Allergy to Japanese herbal medicine 4) Severe comorbidities, such as liver disease, renal disease, heart disease, lung disease, hematologic disease and metabolic disease 5) Electrolyte abnormalities 6) Cardiac pacemaker 7) Severe mental disorder 8) Pregnancy 9) Patient who is judged to be unsuitable for inclusion in the study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of the ratio of skeletal muscle mass to body weight
- Secondary Outcome Measures
Name Time Method (1) Change of body composition (2) Change of nutritional parameters (3) Adverse events and postoperative complications