Clinical trial NCT05739071: JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer
Official title: JING SI HERBAL TEA in the Treatment of Lower Urinary Tract Symptoms After Intravesical Therapy in Patients With Bladder Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Intravenous Drug Usage
Bladder Cancer
Herbal Interaction
Keywords: Intravesical installaion
Bladder cancer
Lower urinary tract symptoms
JING SI HERBAL TEA
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind (patients and attending physicians), parallel design Experimental group: JING SI HERBAL TEA, twice a day, every time 1 sachet for 3 days after each intravesical installation Control group: Placebo, twice a day, every time 1 sachet for 3 days after each intravesical installation
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary symptoms
timeFrame: The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Secondary outcomes:
measure: Life quality
timeFrame: The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Buddhist Tzu Chi General Hospital, Taipei branch
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Shu-Yu Wu, bachelor
role: STUDY_DIRECTOR
References: