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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months.
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.
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score
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).
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12
Change in Short Form 12 Health Survey (SF-12) Score
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.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12
Incidence of Adverse Events
Number of participants with treatment-related adverse events or side effects to evaluate safety.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.