JING SI HERBAL TEA Use as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The placebo is identical in appearance and packaging to the investigational product to maintain the blind.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients.
- •Diagnosed with Chronic Pelvic Pain Syndrome (CPPS) at the investigational site.
- •Currently receiving continuous follow-up and medical treatment.
Exclusion Criteria
- •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).
- •Duration of symptoms less than 3 months.
- •History of recurrent urinary tract infections.
- •Diagnosed with malignancy.
- •Hospitalization for other diseases within the past 3 months.
- •Unwilling to participate in the study.
Arms & Interventions
Jing Si Herbal Tea Group
Participants in this group will receive Jing Si Herbal Tea as an adjuvant therapy. They are instructed to take the tea orally twice daily (BID) - one pack in the morning and one in the evening - for a duration of 12 months.
Intervention: Jing Si Herbal Tea (Dietary Supplement)
Placebo Control Group
Participants in this group will receive a matching placebo. They are instructed to take the placebo orally twice daily (BID) - one pack in the morning and one in the evening - for a duration of 12 months.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score
Time Frame: 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 Outcomes
- Change in Short Form 12 Health Survey (SF-12) Score(Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12)
- Incidence of Adverse Events(Up to 12 months)
Investigators
Chun-Kai Hsu
Attending Physician
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation