JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05739071
• Other study ID #: 11-XD-132
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2023
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Herbal Interaction
• Intravenous Drug Usage
• Lower Urinary Tract Symptoms
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• JING SI HERBAL TEA
JING SI HERBAL TEA is a food, contain with herbal extracts
• Placebo
Placebo will have the same appearance as JING SI HERBAL TEA

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital, Taipei branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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