JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05739071

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Intravenous Drug Usage Bladder Cancer Herbal Interaction	Dietary Supplement: JING SI HERBAL TEA Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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 installationDouble 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

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental (group 1) 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 JING SI HERBAL TEA is a food, contain with herbal extracts
Placebo Comparator: Control (group 2) This group will receive two sachets of placebo a day (same way as group 1).	Dietary Supplement: Placebo Placebo will have the same appearance as JING SI HERBAL TEA

Arm

Intervention/Treatment

Experimental: Experimental (group 1)

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

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

Placebo Comparator: Control (group 2)

This group will receive two sachets of placebo a day (same way as group 1).

Dietary Supplement: Placebo

Placebo will have the same appearance as JING SI HERBAL TEA

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Buddhist Tzu Chi General Hospital, Taipei branch	Taipei		Taiwan	231

Sponsors and Collaborators

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

Study Director: Shu-Yu Wu, bachelor, Taichung Tzu Chi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

ClinicalTrials.gov Identifier:

NCT05739071

Other Study ID Numbers:

11-XD-132

First Posted:

Feb 22, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Intravesical installaion

Bladder cancer

Lower urinary tract symptoms

JING SI HERBAL TEA

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Feb 22, 2023