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临床试验/NCT07357142
NCT07357142尚未招募不适用

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

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
1
主要终点
Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

The placebo is identical in appearance and packaging to the investigational product to maintain the blind.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Jing Si Herbal Tea (Dietary Supplement)

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.

干预措施: Placebo (Other)

结局指标

主要结局

Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score

时间窗: 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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun-Kai Hsu

Attending Physician

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

研究点 (1)

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