Randomized, double-blind trial to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis
- Conditions
- Acute diverticulitis of colon
- Registration Number
- JPRN-UMIN000027381
- Lead Sponsor
- Department of Japanese-Traditional (Kampo) Medicine, Kanazawa University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 170
Not provided
1. Patients with severe dysfunction in the following organs, based on blood tests within four weeks before treatment starts Renal function serum creatinine value 1.5-fold greater than the upper limit of the institutional standard Liver function serum AST value or serum ALT value 3-fold greater than the upper limit of the institutional standard Central nervous function encephalopathy or a patient suspected of it Electrolytes serum sodium less than 125, serum potassium less than 3.3 2. Patients considered highly likely to exhibit abscess perforation due to malnutrition, serum Albumin less than 2.5 3. Patients with symptoms of obstructive ileus 4. Patients who exhibit chronic anorexia, abdominal pain, and/or diarrhea symptoms before the onset of colorectal diverticulitis 5. Before the onset of colorectal diverticulitis, performance status, an indicator of general condition and the degree of restriction of the patient's daily life, of more than three 6. Patients who have a history of DBT administration 7. Patients undergoing treatment with insulin preparations 8. Immunocompromised patients 9. Pregnant women and those in the postpartum period 10. Patients with advanced allergy to Kampo formulas 11. Patients who the doctor considers to be inappropriate for inclusion in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of fever-down (below 38 degrees) within 3 days
- Secondary Outcome Measures
Name Time Method Hospitalization days Changes in inflammatory response Number of days before oral intake Recurrence rate Rate to loss abdominal pain within 4 days Types and frequencies of adverse events or side effects