Jing Si Herbal Tea as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome (JSHT-CPPS)

JING SI HERBAL TEA Use 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pelvic Pain Syndrome (CPPS)
• Intervention / Treatment: Dietary supplement: Jing Si Herbal Tea; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Kai Hsu, Doctor of Medicine; Phone Number: 67745 +886-2-6628-9779; Email: svevi0614@gmail.com
• Study Contact Backup: Name: Wan-ling Young, Research Assistant; Phone Number: 64124 +886-2-6628-9779; Email: lisayoung1345@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Taipei Tzu Chi Hospital
    • Contact: Chun-Kai Hsu, MD; Phone Number: 67745 +886-2-6628-9779; Email: svevi0614@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Jing Si Herbal Tea; Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months.
Placebo Comparator: 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Herbal Medicine; Chronic Pelvic Pain Syndrome; CPPS; Jing Si Herbal Tea
• Other Study ID Numbers: 14-IRB062; TCMF-JCT 115-06 (Other Grant/Funding Number: Buddhist Tzu Chi Medical Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect participant privacy and confidentiality. The informed consent form signed by participants does not include provisions for the public release of individual-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No