臨床研究等提出・公開システム

Japanese

Date of registration	May. 21, 2026
Last modified on	May. 21, 2026
Trial ID	jRCT1061260022

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

Contact for Scientific Queries	Name	Abe Yohei
	Affiliation	Kagawa University
	Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, JAPAN
	Telephone	+81-87-898-5111
	E-mail	abe.yohei.1x@kagawa-u.ac.jp
Contact for Public Queries	Name	Abe Yohei
	Affiliation	Kagawa University
	Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, JAPAN
	Telephone	+81-87-898-5111
	E-mail	abe.yohei.1x@kagawa-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		May. 21, 2026
Target sample size		60
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-Muscle Invasive Bladder Neoplasms
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.
Health Condition(s) Keyword		Non-muscle-invasive bladder cancer, bladder cancer, urothelial carcinoma
Intervention(s) Keyword		Juzentaihoto, intravesical BCG therapy, Kampo medicine, oral administration
Health Condition(s) Code		D000093284
Intervention(s) Code		D000093284
Primary Outcome(s)		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(s)		1. CR (Complete Response) rate within 6 months 2. Duration of CR 3. Bladder-intact rate 4. Progression-free survival (PFS)

Name of Certified Review Board	Kagawa University Hospital Certified Review Board for Clinical Research
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, JAPAN, Kagawa
Telephone	+81-87-891-2011
E-Mail	kenkyu-m@kagawa-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 30, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none