NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Non-Muscle Invasive Bladder Neoplasms
Date of first enrollment	21/05/2026
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	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-Guerin (BCG) therapy.

Outcome(s)

Primary Outcome	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 Outcome	1. CR (Complete Response) rate within 6 months 2. Duration of CR 3. Bladder-intact rate 4. Progression-free survival (PFS)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.