NCT07357142

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Dec 2030

First Submitted

Initial submission to the registry

January 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

January 13, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

Chronic Pelvic Pain SyndromeCPPSJing Si Herbal TeaHerbal Medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Jing Si Herbal Tea Group

EXPERIMENTAL

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

Placebo Control Group

PLACEBO COMPARATOR

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

Interventions

PlaceboOTHER

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.

Placebo Control Group
Jing Si Herbal TeaDIETARY_SUPPLEMENT

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

Jing Si Herbal Tea Group

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients.
  • Diagnosed with Chronic Pelvic Pain Syndrome (CPPS) at the investigational site.
  • Currently receiving continuous follow-up and medical treatment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

Location

Central Study Contacts

Chun-Kai Hsu, Doctor of Medicine

CONTACT

Wan-ling Young, Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The placebo is identical in appearance and packaging to the investigational product to maintain the blind.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 21, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations