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NCT Number: NCT07357142

Jing Si Herbal Tea as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome

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.

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Key information

Conditions

Chronic Pelvic Pain Syndrome (CPPS)

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jing Si Herbal Tea

Dietary Supplement

Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months.

Placebo

Other

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.

Primary outcomes

  1. 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

  1. Change in Short Form 12 Health Survey (SF-12) Score

    Time frame: 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.

  2. Incidence of Adverse Events

    Time frame: Up to 12 months

    Number of participants with treatment-related adverse events or side effects to evaluate safety.

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Kai Hsu, Doctor of Medicine

CONTACT

[email protected]

+886-2-6628-9779 ext. 67745

Wan-ling Young, Research Assistant

CONTACT

[email protected]

+886-2-6628-9779 ext. 64124

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

JING SI HERBAL TEA Use as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome

Acronym: JSHT-CPPS

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 21, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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