Clinical trial NCT06584786: Therapeutic Effects of Jing Si Herbal Tea for COPD
Official title: Therapeutic Effects of Jing Si Herbal Tea for Chronic Obstructive Pulmonary Disease: A Comprehensive Investigation From Clinical to Basic Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Airway Disease
Keywords: COPD
Jing Si herbal tea
damage-associated molecular patterns
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the COPDAE part, the control group received standard treatment including intravenous steroids, inhaled butanyl and ipratropium, and parenteral antibiotics for secondary infections. Placebo mimics of JSHT were administered to the control group. The JSHT group received standard COPDAE treatment plus JSHT (1 pack thrice daily) for one week. For patients with stable COPD, the control group received standard inhaled medications according to the GOLD guidelines. Placebo mimics of JSHT were administered to the control group. The JSHT group additionally received one pack of JSHT daily for three months.
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD), a leading cause of global mortality, significantly impairs health-related quality of life (HRQL). COPD is characterized by airway inflammation and lung tissue damage. Jing Si herbal tea (JSHT) is known to have anti-inflammatory effects but has not been explored for treating COPD. This study investigated the potential of JSHT as an adjuvant therapy for COPD. This randomized controlled study focused on patients with COPD in the exacerbation and stable phases. The control group received the standard treatment, and the JSHT group received the standard treatment plus JSHT. Both groups underwent HRQL assessments, blood tests, and cellular studies involving five different groups to assess the effect of JSHT on damage-associated molecular patterns (DAMPs) and inflammatory markers.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a common lung disease that impairs airflow and causes breathing difficulties. COPD is a major contributor to chronic health issues and mortality globally; it ranked as the third leading cause of death worldwide, resulting in 3.23 million fatalities in 2019. Individuals with COPD typically develop lung damage or airway obstruction. This condition is characterized by several common symptoms, including coughing, phlegm production, difficulty breathing, wheezing, and fatigue. The challenge in breathing frequently leads to reduced exercise endurance and diminished daily activity levels, which negatively affects health-related quality of life (HRQL). Despite following the optimal treatment provided by the Global Initiative for chronic obstructive lung disease (GOLD) guidelines, patients with COPD still experience significant disease effects. This underscores the need for continued research on potential therapies for COPD.

COPD is a gradually progressive airway disease. Harmful agents such as cigarettes and infection are the primary risk factor for COPD. The development of COPD involves airway inflammation and damage to the lung tissue. Persistent exposure to harmful agents damages lung epithelial cells, playing a crucial role in the pathogenesis of COPD. During this process, damage-associated molecular patterns (DAMPs) are released, triggering inflammatory pathways and the release of pro-inflammatory cytokines such as interleukin (IL)-1, IL-6, IL-8, and tumor necrosis factor (TNF)-α. These cytokines further activate inflammatory cells, such as macrophages and neutrophils, leading to further damage to lung tissues. These inflammatory mechanisms offer insights into potentially effective treatments.

Jing Si Herbal Tea (JSHT) is a herbal blend formulated to regulate the immune system and treat inflammatory respiratory conditions. A recent study showed that combining JSHT with standard treatment in patients with COVID-19 improved clinical C-reactive protein levels and alleviated infections more effectively than standard treatment alone. Additionally, using JSHT decreases the risk of intubation, critical conditions, and mortality. This suggests that JSHT may be a beneficial adjunct therapy for patients with COVID-19. However, the therapeutic effects of JSHT in COPD have not yet been studied.

Given that JSHT was designed for immune regulation and treatment of inflammatory diseases, investigators hypothesized that JSHT could be beneficial for patients with COPD. Therefore, investigators study the therapeutic effects and precise mechanisms of action of JSHT in COPD. This study provides a possible strategy for using JSHT as an adjuvant therapy for COPD.

Eligibility criteria: Inclusion Criteria:

* COPD patients willing to enter this study

Exclusion Criteria:

* not COPD patients, no willing to enter this study

Primary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: Assess at baseline and three months of treatment
measure: Modified Medical Research Council (mMRC)
timeFrame: Assess at baseline and three months of treatment
measure: Brief Symptom Rating Scale (BSRS-5)
timeFrame: Assess at baseline and three months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
state: Xindan
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Chou-Chin Lan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Tzu Chi Hospital
name: Yao-Kuang Wu, MD
role: STUDY_DIRECTOR
References: