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A randomized controlled multicenter clinical study evaluating the postoperative administration of Bang'an Bazheng granules combined with epirubicin infusion in the treatment of bladder cancer (damp-heat type) with epirubicin infusion as control

A randomized controlled multicenter clinical study evaluating the postoperative administration of Bang'an Bazheng granules combined with epirubicin infusion in the treatment of bladder cancer (damp-heat type) with epirubicin infusion as control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000406
Enrollment
Unknown
Registered
2025-02-25
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

Treatment Group:Epirubicin bladder instillation + taking Bangan Bazheng granules for 12 months: Each time epirubicin bladder instillation + taking Bangan Bazheng granules for 1 week (3 times a day)
Control group:Epirubicin intravesical instillation for 12 months

Sponsors

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18 to 70 years; (2) Patients diagnosed with non-muscle invasive bladder cancer (Ta T1) by clinical imaging combined with TURBT; (3) Patients must meet the TCM syndrome diagnostic criteria for damp-heat type; (4) Signed informed consent and good compliance.

Exclusion criteria

Exclusion criteria: (1) Women who are pregnant or preparing to become pregnant or breastfeeding; (2) Patients with obvious major diseases such as serious cardiovascular and cerebrovascular diseases nervous system diseases motor organ diseases etc. as well as patients with obvious disabilities or visual and hearing impairments that seriously affect their quality of life; (3) Patients who are allergic to Bangan Bazheng Granules epirubicin or its components should be excluded to ensure the safety of the study; (4) Patients who are participating in clinical studies of other drugs should not be included in this study to avoid drug interactions and the complexity of evaluation; (5) Patients with other systemic malignant tumors; (6) Patients with autoimmune diseases;

Design outcomes

Primary

MeasureTime frame
Cystoscopy(Proportion of subjects who relapsed bladder cancer within 1 year of treatment);

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Points;Urinary ultrasound (residual urine);ICIQ-M/F-LUTS;Urine flow rate;

Countries

China

Contacts

Public ContactKaifa Tang

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

doc.tangkf@hotmail.com15285182092

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026