A study of Juzentaihoto in patients with bladder cancer receiving BCG intravesical therapy

A prospective comparative study evaluating the efficacy and safety of Juzentaihoto in patients with non-muscle invasive bladder cancer receiving intravesical Bacillus Calmette-Guerin therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1061260022

Enrollment

Registered

2026-05-21

Start date

2026-05-21

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

Non-Muscle Invasive Bladder Neoplasms Non-muscle-invasive bladder cancer, bladder cancer, urothelial carcinoma

Interventions

Juzentaihoto will be administered orally to patients in the treatment group at a daily dose of 7.5 g, divided into three doses, starting on the day of initiation of intravesical Bacillus Calmette-Guer

D000093284

Juzentaihoto, intravesical BCG therapy, Kampo medicine, oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who underwent transurethral resection of bladder tumor (TURBT) at our institution. 2. Patients histologically diagnosed with T1 disease or carcinoma in situ (CIS). 3. Patients who provided consent to be prescribed and take Juzentaihoto.

Exclusion criteria

Exclusion criteria: 1. Patients who refused to provide consent for participation in this study. 2. Patients who received other Kampo medicines within 2 weeks before the initiation of intravesical Bacillus Calmette-Guerin (BCG) therapy. 3. Patients who are unable to take oral medications. 4. Patients with a known allergy to Kampo medicines.

Design outcomes

Primary

Measure	Time frame
1. Rate of achievement of adequate Bacillus Calmette-Guerin (BCG) therapy 2. BCG continuation rate 3. Quantification of adverse events and changes over time using the following questionnaires: 4. International Prostate Symptom Score (IPSS) 5. Quality of Life (QOL) score 6. Pain-related scores of the Quality of Life Questionnaire for Non-Muscle Invasive Bladder Cancer (QLQ-NMIBC24)	—

Secondary

Measure	Time frame
1. CR (Complete Response) rate within 6 months 2. Duration of CR 3. Bladder-intact rate 4. Progression-free survival (PFS)	—

Contacts

Public ContactYohei Abe

Kagawa University

abe.yohei.1x@kagawa-u.ac.jp+81-87-898-5111

Outcome results

None listed

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