Jing Si Herbal Tea as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Jing Si Herbal Tea, Placebo.
- Кому может быть актуально
- Состояния в реестре: Chronic Pelvic Pain Syndrome (CPPS). Базовые параметры: 18 лет — 100 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
JING SI HERBAL TEA Use as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome
Обзор
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.
Подробное описание
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.
Вмешательства
- Пищевая добавка Jing Si Herbal Tea
Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months. - Другое 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.
Первичные конечные точки
- Change in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score [Срок оценки: Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12]
Вторичные конечные точки (2)
- Change in Short Form 12 Health Survey (SF-12) Score [Срок оценки: Baseline, Month 1, Month 2, Month 3, Month 6, and Month 12]
- Incidence of Adverse Events [Срок оценки: Up to 12 months]
Критерии участия
Критерии включения
- Male patients.
- Diagnosed with Chronic Pelvic Pain Syndrome (CPPS) at the investigational site.
- Currently receiving continuous follow-up and medical treatment.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Taipei Tzu Chi Hospital — New Taipei City
Идентификаторы
NCT: NCT07357142 · 14-IRB062 · TCMF-JCT 115-06