Clinical Efficacy of Jing Si Herbal Tea Liquid Packet to Treat Patients With Interstitial Cystitis/Bladder Pain Syndrome

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

20 years - 84 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

80 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Introduction: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a disease of unknown etiology, with clinical characteristics of bladder pain, frequency, urgency, and nocturia. There has been no effective and durable medication to cure this disease. Current research has revealed that chronic bladder wall inflammation and bladder mucosal denudation are the fundamental pathology for clinical symptoms. Using Jing Si Herbal Tea liquid packets may have a therapeutic effect in patients with refractory IC/BPS.

Aim: To investigate the effect of Jing Si Herbal Tea liquid packet intervention added to urological therapy for patients with refractory IC/BPS.

Materials and Methods: This study will enroll patients with IC/BPS who are refractory to various conventional treatments after cystoscopic hydrodistention, antimuscarinic, and painkiller treatments. These patients plan to receive further intravesical IC therapy, such as intravesical hyaluronic acid (HA) instillation, intravesical botulinum toxin A (Botox) injection, intravesical platelet-rich plasma (PRP) injection, or low-energy shock wave (LESW) therapy. The patients will be randomly assigned to receive intravesical IC therapy and placebo (control group) or concomitant IC treatment with Jing Si Herbal Tea liquid packet TID (treatment group) for 3 months. The voiding diary, ICSI, ICPI, VAS, PPBC, GRA, Qmax, Vol, and PVR are also assessed at baseline and at 4, 12, and 20 weeks after treatment. The primary endpoint of this study is the improvement of GRA by 2 points at 12 weeks after treatment.

Assessment: The patients will be investigated using the voiding diary (for frequency of nocturia episodes per day), ICSI, IC problem index (ICPI), Numerical Rating Scale (NRS) of pain, patient perception of bladder condition (PPBC), global response assessment (GRA), maximal flow rate (Qmax), voided volume (Vol), and post-void residual urine (PVR) volume measurement at baseline and after treatment. Urine samples will also be obtained for determination of urinary biomarkers at baseline and after different therapies.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• This study is expected to select patients with IC (non-ulcer type, Glomerulation \>1, interstitial cystitis symptom index (ICSI≧12 points) in the urology outpatient clinic, and use anticholinergic drugs and pain medication treatment. The symptoms have not improved significantly (ICSI≧12). Patients will be asked about their willingness before being selected to confirm that they are willing to accept this clinical trial, and they can be included in this clinical trial after completing the entire course of the treatment test.

Exclusion Criteria:

1. non-IC/BPS patients
2. psychological disease was diagnosed
3. non-NIDDK criteria (Hunner\'s ulcer type)
4. Under-primary or illiterate respondents
5. patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow up
6. Patients with bladder outlet obstruction on enrollment
7. Patients with post-void residual \> 150ml
8. Patients with an uncontrolled confirmed diagnosis of acute urinary tract infection
9. Patients have laboratory abnormalities at screening including:

ALT\> 3 x upper limit of normal range AST\> 3 x upper limit of normal range Patients have abnormal serum creatinine level \>2 x upper limit of normal range
10. Patients who cannot used urinary catheter to treat.
11. Female patients who are pregnant, lactating, or childbearing potential without contraception.
12. Patients with any other serious disease considered by the investigator not in the condition to enter the trial
13. Patients cannot record the voiding diary

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Hualien Tzu Chi General Hospital

Study start

Aug 31, 2026 Actual

Primary completion

Aug 31, 2026 Actual

Study completion

Dec 1, 2026 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.