Lower Urinary Tract SymptomsNCT05739071
JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer
A study testing JING SI HERBAL TEA in people with Lower Urinary Tract Symptoms and Intravenous Drug Usage, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lower Urinary Tract Symptoms, Intravenous Drug Usage, Bladder Cancer
- What is being tested?
- JING SI HERBAL TEA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2023to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis bladder cancer
- Under intravesical installation therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Buddhist Tzu Chi General Hospital, Taipei branch
Taipei, Taiwan, 231
About this study
Official title: JING SI HERBAL TEA in the Treatment of Lower Urinary Tract Symptoms After Intravesical Therapy in Patients With Bladder Cancer
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.
Read the 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.
- Being tested
- JING SI HERBAL TEA, Placebo
- Keywords
- Intravesical installaion, Bladder cancer, Lower urinary tract symptoms, JING SI HERBAL TEA
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JING SI HERBAL TEADietary supplement
JING SI HERBAL TEA is a food, contain with herbal extracts
PlaceboDietary supplement
Placebo will have the same appearance as JING SI HERBAL TEA
| Study group | Role | What they receive |
|---|---|---|
| Experimental (group 1) | Experimental | This group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening). Receives: Dietary Supplement: JING SI HERBAL TEA |
| Control (group 2) | Placebo comparator | This group will receive two sachets of placebo a day (same way as group 1). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
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.
Measured: The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start22 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Yu Wu, bachelor, Study director, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739071
- Sponsor's protocol ID
- 11-XD-132
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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