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| ID | Type | Description | Link |
|---|---|---|---|
| TCMF-JCT 115-06 | Other Grant/Funding Number | Buddhist Tzu Chi Medical Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jing Si Herbal Tea | Dietary Supplement | Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Kai Hsu, Doctor of Medicine | Contact | +886-2-6628-9779 | 67745 | svevi0614@gmail.com |
| Wan-ling Young, Research Assistant | Contact | +886-2-6628-9779 | 64124 | lisayoung1345@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | New Taipei City | 231 | Taiwan |
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.
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The placebo is identical in appearance and packaging to the investigational product to maintain the blind.
| 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. |
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| Incidence of Adverse Events | Number of participants with treatment-related adverse events or side effects to evaluate safety. | Up to 12 months |