An interventional study of Jing Si Herbal Tea liquid packet in Interstitial Cystitis and Multimodal Intervention, sponsored by Hualien Tzu Chi General Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 20 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hualien Tzu Chi General Hospital · Not applicable, Interventional, and Health services 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.
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. Patients with IC/BPS have increased anxiety, depression, loss of social relationships, and a high suicide rate due to intolerable symptoms. Current research has revealed that chronic bladder wall inflammation and bladder mucosal denudation are the fundamental pathology for clinical symptoms. After medical treatment or intravesical therapy, urinary inflammatory biomarkers may decrease, and this reduction is associated with clinical symptom improvement. Jing-Si Herbal Tea is a traditional Chinese medicine product that has been shown to have potential effects on autonomic nervous system modulation, immunomodulation, and antioxidant activity. Using Jing-Si-Herbal-Tea may have a therapeutic effect in patients with refractory IC/BPS.
Material and Methods: This study will enroll patients with IC/BPS who are refractory to various conventional treatments (an interstitial cystitis symptom index (ICSI) >12 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 investigated for the voiding diary (for frequency and 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 urinary biomarker determination at baseline and after different therapies. The patients will be randomly assigned to receive intravesical IC therapy and placebo (control group) or concomitant IC treatment with Jing-Si-Herbal-Tea 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, 8, and 12 weeks after treatment. The primary endpoint of this study is the improvement of GRA by 2 points at 12 weeks after treatment. The urinary biomarker levels will also be compared before baseline and after treatment. Secondary endpoints include ICSI and ICPI, assessed by self-report of IC/BPS severity and NRS for pain severity; the range of ICSI is 0 to 20 points, and the ICPI total score is 0 to 16 points. Bladder pain was assessed using a self-rated 11-point NRS for severity.
Expected results: The investigators expect IC/BPS patients in the treatment group (combined IC treatment and Jing-Si-Herbal-Tea treatment) to have significantly greater improvement in GRA after 12 weeks of treatment. The investigators also expect that improvement in bladder pain (as measured by NRS) might be the most effective indicator of treatment outcome.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 80 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Hualien Tzu Chi General Hospital is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients have laboratory abnormalities at screening including:
> 3 x AST> 3 x upper limit of normal range Patients have abnormal serum creatinine level >2 x upper limit of normal range
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who meet all eligibility requirements for entry into the study will be randomized into combined bladder treatment or only bladder treatment
Dietary Supplement: Jing Si Herbal Tea liquid packet
Jing Si Herbal Tea liquid packet
Dietary Supplement: Jing Si Herbal Tea liquid packet
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 investigated at baseline and after treatment, at 4 weeks, 8 weeks, 12 weeks, and 20 weeks after the treatment. The primary endpoint of this study is the improvement of GRA by 2 points at 12 weeks after treatment. The urinary biomarker levels will also be compared before baseline and after treatment.
Also known as: Jing Si Herbal Tea liquid packet placebo
Global Response Assessment (GRA) at Week 12
The Global Response Assessment (GRA) evaluates patient-reported overall changes in bladder symptoms following treatment. Higher scores indicate greater perceived improvement.
Time frame: Week 12
Change in Interstitial Cystitis Symptom Index (ICSI)
The Interstitial Cystitis Symptom Index (ICSI) assesses the severity of urinary frequency, urgency, nocturia, and bladder-related pain. Total scores range from 0 to 20, with higher scores indicating more severe symptoms. Change from baseline will be assessed.
Time frame: Baseline and Week 12
Change in Interstitial Cystitis Problem Index (ICPI)
The Interstitial Cystitis Problem Index (ICPI) measures the degree of bother associated with urinary symptoms. Total scores range from 0 to 16, with higher scores indicating greater symptom-related problems. Change from baseline will be assessed.
Time frame: Baseline and Week 12
Change in Bladder Pain Intensity
Bladder pain intensity is assessed using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Change from baseline will be assessed.
Time frame: Baseline and Week 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hualien Tzu Chi General Hospital