JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

Buddhist Tzu Chi Medical Foundation

Status: Invitation-only

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: JING SI HERBAL TEA

Study type: Interventional

Funder types: Other

Identifiers

NCT05739071

11-XD-132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Experimental (group 1)

Experimental group

Description:

This group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening).

Treatment:

Dietary Supplement: JING SI HERBAL TEA

Control (group 2)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo