JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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JING SI HERBAL TEA in the Treatment of Lower Urinary Tract Symptoms After Intravesical Therapy in Patients With Bladder Cancer

Conditions
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Lower Urinary Tract Symptoms, Intravenous Drug Usage, Bladder Cancer, Herbal Interaction

Intervention / Treatment
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* Dietary Supplement: JING SI HERBAL TEA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental (group 1)<br>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<br>* JING SI HERBAL TEA is a food, contain with herbal extracts<br>|
| Placebo Comparator: Control (group 2)<br>This group will receive two sachets of placebo a day (same way as group 1). | Dietary Supplement: Placebo<br>* Placebo will have the same appearance as JING SI HERBAL TEA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravesical installaion, Bladder cancer, Lower urinary tract symptoms, JING SI HERBAL TEA