Chronic Pelvic Pain Syndrome (CPPS)
Conditions
Keywords
Chronic Pelvic Pain Syndrome, CPPS, Jing Si Herbal Tea, Herbal Medicine
Brief summary
The purpose of this clinical trial is to evaluate the efficacy of Jing Si Herbal Tea as an adjuvant treatment for patients diagnosed with Chronic Pelvic Pain Syndrome (CPPS). The study aims to determine whether adding Jing Si Herbal Tea to standard care can improve clinical symptoms and quality of life in these patients.
Detailed description
Background: Chronic Pelvic Pain Syndrome (CPPS) is a clinically complex condition characterized by persistent pain, often accompanied by lower urinary tract symptoms and other physiological or psychological impacts. Patients frequently lack a definitive, single etiology, necessitating a multimodal treatment approach. Current standard management often involves the combined use of antibiotics (for prevention and treatment of bacterial infections), anti-inflammatory drugs (for symptom control), and alpha-blockers (to improve voiding symptoms). However, these treatments are associated with known side effects, concerns regarding future antibiotic resistance, and suboptimal efficacy in many patients. While local electrical stimulation and acupuncture are viable alternatives, accessibility and convenience remain significant barriers for patients. Study Rationale: This study aims to evaluate the combined use of "Jing Si Herbal Tea" (JSHT) with standard pharmacological treatment. The objective is to alleviate patient symptoms, improve quality of life, reduce medication usage, and decrease healthcare expenditures. Intervention Mechanism: Jing Si Herbal Tea (JSHT) is a multi-herbal formula containing various bioactive compounds known for their anti-inflammatory and immunomodulatory properties. It is proposed as an adjuvant therapy to alleviate symptoms of CPPS. The anti-inflammatory mechanism of JSHT is attributed to its active ingredients, including ovatodiolide, glycyrrhizin, eupatilin, and rosmarinic acid. These compounds exert their effects by inhibiting the NF-κB signaling pathway, reducing the secretion of pro-inflammatory cytokines (such as TNF-α and IL-6), and decreasing oxidative stress.
Interventions
DIETARY_SUPPLEMENTJing Si Herbal Tea
Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months.
OTHERPlacebo
Oral administration of a matching placebo, 2 packs daily (one in the morning and one in the evening) for 12 months. The placebo is identical in appearance and packaging to the investigational product.
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The placebo is identical in appearance and packaging to the investigational product to maintain the blind.
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Male patients. 2. Diagnosed with Chronic Pelvic Pain Syndrome (CPPS) at the investigational site. 3. Currently receiving continuous follow-up and medical treatment.
Exclusion criteria
1. Female patients (Excluded because the standard treatment, alpha-blockers, is not approved or reimbursed by the National Health Insurance for this indication in women in Taiwan). 2. Duration of symptoms less than 3 months. 3. History of recurrent urinary tract infections. 4. Diagnosed with malignancy. 5. Hospitalization for other diseases within the past 3 months. 6. Unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score | Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12 | The NIH-CPSI is a standardized 9-item questionnaire used to assess symptom severity in patients with CPPS across three domains: Pain, Urinary Symptoms, and Quality of Life. The total score ranges from 0 to 43, with higher scores indicating more severe symptoms. Severity is categorized as Mild (0-14), Moderate (15-29), and Severe (30-43). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Form 12 Health Survey (SF-12) Score | Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12 | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It produces two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. |
| Incidence of Adverse Events | Up to 12 months | Number of participants with treatment-related adverse events or side effects to evaluate safety. |
Countries
Taiwan
Contacts
CONTACTWan-ling Young, Research Assistant
CONTACTChun-Kai Hsu, Doctor of Medicine
Outcome results
None listed