Skip to content

Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis

Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis - Hange-shashin-to for refractory pouchitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010004
Enrollment
15
Registered
2013-02-09
Start date
2013-02-12
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

pouchitis

Interventions

Hange-shashin-to administration

Sponsors

Department of lower gastroenterological surgery, Hyogo college of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with chronic relapsing-remitting pouchitis after restorative proctocolectomy for ulcerative colitis. PDAI scoreis more than7points. Candidate has to agree to be enrolled for the study under sufficient written informed consent.

Exclusion criteria

Exclusion criteria: 1)Concomitant administrations of antibiotics within 2weeks. 2)Concomitant administrations of Chinese medicine within 2weeks. 3) A patient, who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period. 4) A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.

Design outcomes

Primary

MeasureTime frame
Efficacy of treatment was defined Pouchitis Disease Activity Index score with each parameter which includes clinical symptoms, endoscopic appearance, and histopathological findings. These parameters were assessed at before and after treatment.

Countries

Japan

Contacts

Public ContactHiroki Matsuoka

Hyogo college of Medicine gastroenterological surgery

m-hiro2s@hyo-med.ac.jp0798-45-6372

Outcome results

None listed

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