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NCT Number: NCT05739071

JING SI HERBAL TEA and Urinary Tract Symptoms in 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.

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Key information

Conditions

Lower Urinary Tract Symptoms Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Herbal Interaction Intravenous Drug Usage Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urological Manifestations

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Tzu Chi General Hospital, Taipei branch

Taipei, Taiwan, 231

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jing Si Herbal Tea

Dietary Supplement

JING SI HERBAL TEA is a food, contain with herbal extracts

Placebo

Dietary Supplement

Placebo will have the same appearance as JING SI HERBAL TEA

Primary outcomes

  1. 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

    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 outcomes

  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

    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.

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 22, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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