JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

NCT05739071 | Enrolling By Invitation

• 1 other identifier: 11-XD-132
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Intravenous Drug Usage; Bladder Cancer; Herbal Interaction

Keywords

Intravesical installaion; Bladder cancer; Lower urinary tract symptoms; JING SI HERBAL TEA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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).

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).

Dietary Supplement: Placebo

Interventions

JING SI HERBAL TEA DIETARY_SUPPLEMENT

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

Experimental (group 1)

Placebo DIETARY_SUPPLEMENT

Placebo will have the same appearance as JING SI HERBAL TEA

Control (group 2)

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis bladder cancer
• Under intravesical installation therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital, Taipei branch

Taipei, Taiwan, 231, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Shu-Yu Wu, bachelor

  Taichung Tzu Chi Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 22, 2023
• Study Start: February 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)