Health TrialsbyHealthPanel

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

ConditionChronic Pelvic Pain Syndrome (CPPS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-100
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients.

Diagnosed with Chronic Pelvic Pain Syndrome (CPPS) at the investigational site.

Currently receiving continuous follow-up and medical treatment.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Jing Si Herbal Tea GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

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).

Time frame
Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12

Secondary outcomes

1

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
2

Incidence of Adverse Events

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

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: