A randomized controlled trials regarding perioperative management with oligopeptides(PN-2) in patients with lower gastrointestinal diseases.
Phase 2
- Conditions
- lower gastrointestinal diseases
- Registration Number
- JPRN-UMIN000010810
- Lead Sponsor
- Osaka University Graduate School of Medicine Department of Complementary and Alternative Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with the following diseases. (cirrhosis, chronic renal failure, diabetes with insulin therapy and so on) 2) Patients with steroid treatment 3) Patients with a disorder of amino acid metabolism. 4) Patients with food allergy. 5) Patients less than 20 years old. 6) Patients have experience of chemotherapy. 7) Patients judged to be inappropriate for this study from the doctor in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We evaluate the safety of 'PN-2' by checking hematology,blood biochemistry, urine test and the adverse events by following CTCAE v4.0 index. Evaluations as above are carried out three times,i.e.;seven days before surgery, just before surgery and about 10 days after surgery.
- Secondary Outcome Measures
Name Time Method We evaluate the efficiency of 'PN-2' by checking the following indices: aminogram, immunological tests, wound hearing, complications and length of hospitalization. Evaluations as above are carried out three times,i.e.; seven days before surgery, just before surgery and about 10 days after surgery.