Trials / Not Yet Recruiting
Not Yet RecruitingNCT07357142
Jing Si Herbal Tea as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome
JING SI HERBAL TEA Use as Adjuvant Treatment in Patients With Chronic Pelvic Pain Syndrome
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Academic / Other
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Jing Si Herbal Tea | Oral administration, 2 packs daily (one in the morning and one in the evening) for 12 months. |
| OTHER | 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2029-12-31
- Completion
- 2030-12-31
- First posted
- 2026-01-21
- Last updated
- 2026-02-04
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT07357142. Inclusion in this directory is not an endorsement.