JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JING SI HERBAL TEA, Placebo.
- Who it may be relevant to
- Registry conditions: Lower Urinary Tract Symptoms, Intravenous Drug Usage, Bladder Cancer, Herbal Interaction. Basic parameters: 20 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
JING SI HERBAL TEA in the Treatment of Lower Urinary Tract Symptoms After Intravesical Therapy in Patients With Bladder Cancer
Overview
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.
Interventions
- Dietary supplement JING SI HERBAL TEA
JING SI HERBAL TEA is a food, contain with herbal extracts - Dietary supplement Placebo
Placebo will have the same appearance as JING SI HERBAL TEA
Primary outcome measures
- Urinary symptoms [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]
Secondary outcome measures (1)
- Life quality [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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Buddhist Tzu Chi General Hospital, Taipei branch — Taipei
Identifiers
NCT: NCT05739071 · 11-XD-132