JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

NCT ID: NCT05739071

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2027-12-31

Brief Summary

To identify the effects of JING SI HERBAL TEA in the treatment of lower urinary tract symptoms after intravesical therapy in patients with bladder cancer.

Detailed Description

The patients with bladder cancer usually required trans urethral resection of bladder tumor (TUR-BT). Post-operative intravesical installation therapy is standard therapy. However, new onset lower urinary tract symptoms often occurred after these installation therapies. JING SI HERBAL TEA is a food contain of many herbal extracts with anti-inflammation effects. The current study is to find out the effects of JING SI HERBAL TEA in the treatment of this condition.

The patients will be divided into two groups by randomly assigned (estimated case number=100, experimental: control = 1: 1). The first group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening). The second group will receive two sachets of placebo a day (same way as group 1). The therapy will be three days after each intravesical installation therapies.

The outcome evaluations will use the American Urological Association Symptom Index and 12-Item Short Form Survey (SF-12). The baseline symptoms will be recorded before the first intravesical therapy. Patients will be asked to fill out the questionnaire every week (the same time for the next installation). Every other standard cancer therapies will not be will not be affected.

Conditions

Lower Urinary Tract Symptoms; Intravenous Drug Usage; Bladder Cancer; Herbal Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental (group 1)

This group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening).

Group Type: EXPERIMENTAL

JING SI HERBAL TEA

Intervention Type: DIETARY_SUPPLEMENT

JING SI HERBAL TEA is a food, contain with herbal extracts

Control (group 2)

This group will receive two sachets of placebo a day (same way as group 1).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo will have the same appearance as JING SI HERBAL TEA

Interventions

JING SI HERBAL TEA

JING SI HERBAL TEA is a food, contain with herbal extracts

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo will have the same appearance as JING SI HERBAL TEA

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis bladder cancer
• Under intravesical installation therapy

Exclusion Criteria

• Patients under 20 years old or greater than 100 years old
• Women with pregnancy or breastfeeding plans
• Bladder cancer are being treated in another hospital
• Had admitted due to other disease in the past 3 months
• Unable to understand the questionnaire

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu-Yu Wu, bachelor

Role: STUDY_DIRECTOR

Taichung Tzu Chi Hospital

Locations

Buddhist Tzu Chi General Hospital, Taipei branch

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

11-XD-132

Identifier Type: -

Identifier Source: org_study_id