JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

Not Applicable

• Conditions: Intravenous Drug Usage; Bladder Cancer; Herbal Interaction; Lower Urinary Tract Symptoms
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: JING SI HERBAL TEA

• Registration Number: NCT05739071
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-13
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Study Start: 2023-03
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (group 2)	Placebo	This group will receive two sachets of placebo a day (same way as group 1).
Experimental (group 1)	JING SI HERBAL TEA	This group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening).

Primary Outcome Measures

Name	Time	Method
Urinary symptoms	The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Life quality	The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks	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.

Trial Locations

Locations (1)

Buddhist Tzu Chi General Hospital, Taipei branch; 🇨🇳 Taipei, Taiwan