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Randomized, double-blind trial to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis

Randomized, double-blind trial to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis - RCT to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027381
Enrollment
170
Registered
2017-05-18
Start date
2017-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute diverticulitis of colon

Interventions

daiobotanpito placebo

Sponsors

Department of Japanese-Traditional (Kampo) Medicine, Kanazawa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Moderate to severe diverticulitis Diagnosis will be based on computed tomography images: diverticula-like structure combined with tenderness or abdominal pain, a thickening of colon wall, signs of inflammation of pericolonic fat, tissue density, and vascular involvement. Pericolonic abscess, free air or extravasation, and accumulation of fluid will also be assessed to predict prognosis. 2. Age of at least 20 years and less than 75 years 3. Patients must be able to communicate with the investigators 4. Patients with abdominal pain and/or fever > 37.5 degree 5. After receiving sufficient explanation for participation in this study and achieving sufficient understanding, patients who provide written informed consent for participation.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Rate of fever-down (below 38 degrees) within 3 days

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKeiko Ogawa

Kanazawa University Hospital Department of Japanese-Traditional (Kampo) medicine

okeiko@med.kanazawa-u.ac.jp076-265-2918

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026