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Research on the effect of inhibiting rebleeding in colonic diverticular bleeding

Double-blind Randomized Controlled Trial of the Prevention of Rebleeding by Oren-gedoku-to in Colonic Diverticular Bleeding - CROCODIVE

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051250063
Enrollment
120
Registered
2025-07-08
Start date
2025-08-05
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

Colonic diverticular bleeding Colonic diverticular bleeding

Interventions

Treatment details (dosage, administration, and duration of administration/implementation) Group A: Oren-gedoku-to Group (administration of Oren-gedoku-to + standard treatment: fasting and resting of t
Oren-gedoku-to

Sponsors

Takashi Hisabe
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients of both sexes aged 18 to under 90 years at the time of consent. 2. Patients who visited the hospital within 48 hours of the appearance of hematochezia, and who could not undergo endoscopic hemostasis because a colonoscopy was performed within 24 hours after the visit and colonic diverticular bleeding was diag nosed but no stigmata of recent hemorrhage (SRH ) was observed. 3. Patients with dizziness or palpitations. 4. Patients with Shock index (heart rate/systolic blood pressure) less than 1.0. 5 Patients who have been fully informed of the st udy and have given their consent in writing of thei r own free will.

Exclusion criteria

Exclusion criteria: 1. Patients for whom the responsible diverticulum cannot be identified by colonoscopy but who are scheduled for emergency surgery, arterial emboliz ation, or barium filling due to persistent bleeding. 2. Patients with a history of colorectal resection (e xcluding appendectomy). 3. Patients who have taken Orengedokuto within t he past 2 weeks. 4. Patients with a history of colonic diverticular bl eeding within the past 30 days from the date of en rollment.5. Patients with serious dysfunction of the followin g organs. (Blood tests are acceptable within 4 weeks prior to the start of treatment) Renal function: creatinine level > 1.5 times the up per limit of the facility standard Hepatic function: AST or ALT > 3 times the upper l imit of the institutional standard Electrolyte: Na < 125 mEq/L, K < 3.3 mEq/L 6. Pregnant and lactating women, women who may be pregnant, or women who wish to have a baby. 7. Patients with a history of allergy to Orengedokuto. 8. Patients with advanced malignant colorectal tumor, ulcerative colitis and infetious colitis on colonoscopy at the time of enrollment. 9. Patients who are participating or intend to participate in other clinical trials while participating in this study. 10. Patients for whom it is deemed difficult for the principal investigator (subinvestigator) to participate in the study.

Design outcomes

Primary

MeasureTime frame
Rebleeding rate

Secondary

MeasureTime frame
1. Number of days in hospital 2. Number of days to start oral intake 3. Degree of rebleeding (timing, degree of anemia) 4. Re-rebleeding rate

Contacts

Public ContactAmano Ryosuke

Fukuoka University Chikushi Hospital

ramano1984220@yahoo.co.jp+81-570-02-7777

Outcome results

None listed

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