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Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection.

Assessment for efficacy of combination therapy with Chinese herbal medicine "Shin-bu-to" for Clostridium difficile infection. - Efficacy of "Shin-bu-to" combination therapy for Clostridium difficile infection.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011349
Enrollment
60
Registered
2013-08-05
Start date
2013-08-05
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

Clostridium difficile infection.

Interventions

Basic therapy
Oral Vancomycin 125mg 4 times / day for 10 days. Combination therapy
Oral Vancomycin 125mg 4 times / day for 10 days plus Shin-bu-to (commercially available dry extract) until symptom improve.

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inpatient. Clinically diagnosed with Clostridium difficile infection based on watery diarrhea and positive CD toxin or CD-GDH antigen. Consent to participate this study. Over or equal to 20 year old. Diagnosed as "kyo (weakened)" based on Japanese herbal medicine.

Exclusion criteria

Exclusion criteria: Shock status. Conscious disturbance. Needs intensive care. Unable to take drugs orally due to interstitial dysfunction. Recurrent case of Clostridium difficile infection.

Design outcomes

Primary

MeasureTime frame
Duration of symptoms (mainly diarrhea) between patients with basic therapy and combination therapy.

Secondary

MeasureTime frame
Assessment of prolonged symptoms in day 3 and 5. Assessment of adverse effects. Assessment of dehydration.

Countries

Japan

Contacts

Public ContactHideaki Kato

Yokohama City University Medical Center Infection Control Department

045-261-5656

Outcome results

None listed

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