An interventional study of JING SI HERBAL TEA and Placebo in Lower Urinary Tract Symptoms, Intravenous Drug Usage and Bladder Cancer, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
This group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening).
Dietary Supplement: JING SI HERBAL TEA
This group will receive two sachets of placebo a day (same way as group 1).
Dietary Supplement: Placebo
JING SI HERBAL TEA is a food, contain with herbal extracts
Placebo will have the same appearance as JING SI HERBAL TEA
Urinary symptoms
Change from baseline score at the following time will be recorded. The American urological association symptom index is a 7-item self report measure to assess the urinary symptoms. The score range from 0 to 35, the higher the severity.
Time frame: The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Life quality
Change from baseline score at the following time will be recorded. The 12-item shor form survey is a general health questionaire for life quality evaluation. The higher the value obtained, the more significant the impact on life.
Time frame: The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Plan to share: No — The JING SI HERBAL TEA and Placebo are provided by the Tzu Chi Medical Foundation. We can not determining whether there are sufficient materials to provide the other participants
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation