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Trial Title:
JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer
NCT ID:
NCT05739071
Condition:
Lower Urinary Tract Symptoms
Intravenous Drug Usage
Bladder Cancer
Herbal Interaction
Conditions: Official terms:
Urinary Bladder Neoplasms
Lower Urinary Tract Symptoms
Conditions: Keywords:
Intravesical installaion
Bladder cancer
Lower urinary tract symptoms
JING SI HERBAL TEA
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Care Provider)
Masking description:
Patients will be randomly assigned into the two groups with equal number. The JING SI
HERBAL TEA and placebo have the same outer packaging. One dedicated researcher will be
responsible for random allocation and administration, neither the patients nor the
attending physicians (responsible for recording symptoms) knows the correct grouping.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
JING SI HERBAL TEA
Description:
JING SI HERBAL TEA is a food, contain with herbal extracts
Arm group label:
Experimental (group 1)
Intervention type:
Dietary Supplement
Intervention name:
Placebo
Description:
Placebo will have the same appearance as JING SI HERBAL TEA
Arm group label:
Control (group 2)
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Buddhist Tzu Chi General Hospital, Taipei branch
Address:
City:
Taipei
Zip:
231
Country:
Taiwan
Start date:
March 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Agency class:
Other
Source:
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739071
