Clinical Efficacy of Jing Si Herbal Tea Liquid Packet to Treat Patients With Interstitial Cystitis/Bladder Pain Syndrome
Interstitial Cystitis · Multimodal Intervention
De qué trata este estudio
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- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 20 años - 84 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 80 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
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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
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Jing Si Herbal Tea liquid packet to treat patients with Interstitial Cystitis/Bladder Pain syndrome
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 placebo
Jing Si Herbal Tea liquid packet
Dietary Supplement: Jing Si Herbal Tea liquid packet
Jing Si Herbal Tea liquid packet DIETARY_SUPPLEMENT
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Global Response Assessment (GRA) at Week 12
Plazo: Week 12
The Global Response Assessment (GRA) evaluates patient-reported overall changes in bladder symptoms following treatment. Higher scores indicate greater perceived improvement.
Medidas secundarias
Change in Interstitial Cystitis Symptom Index (ICSI)
Plazo: Baseline and Week 12
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.
Change in Interstitial Cystitis Problem Index (ICPI)
Plazo: Baseline and Week 12
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.
Change in Bladder Pain Intensity
Plazo: Baseline and Week 12
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
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1 centros
Hualien Tzu Chi General Hospital, Tzu Chi Medical FoundationHualien City, TaiwanEstado desconocido
Equipo y fechas
- Patrocinador principal
- Hualien Tzu Chi General Hospital
- Inicio del estudio
- 31 ago 2026 Real
- Finalización primaria
- 31 ago 2026 Real
- Finalización del estudio
- 1 dic 2026 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Jing Si Herbal Tea Liquid Packet Combined Bladder Treatment or Only Bladder Treatment, and to Evaluate the Effect of the Jing Si Herbal Tea Liquid Packet Intervention of IC/BPS
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026