Therapeutic Effects of Jing Si Herbal Tea for COPD

NCT ID: NCT06584786

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Airway Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo group (1)

Placebo group: participants with COPD AE is treated with placebo that mimic JSHT

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo of JSHT

Placebo group (2)

participants with stable COPD treated with placebo that mimic JSHT

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo of JSHT

JSHT group of stable COPD

participants with stable COPD treated with JSHT

Group Type: EXPERIMENTAL

Jing Si herbal tea (JSHT)

Intervention Type: COMBINATION_PRODUCT

JSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635).

JSHT group of COPDAE

participants with COPD AE is treated with JSHT

Group Type: EXPERIMENTAL

Jing Si herbal tea (JSHT)

Intervention Type: COMBINATION_PRODUCT

JSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635).

Interventions

Jing Si herbal tea (JSHT)

JSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635).

Intervention Type: COMBINATION_PRODUCT

Placebo

Placebo of JSHT

Intervention Type: OTHER

Other Intervention Names

Placebo of JSHT

Eligibility Criteria

Inclusion Criteria

• COPD patients willing to enter this study

Exclusion Criteria

• not COPD patients, no willing to enter this study

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chou-Chin Lan, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Yao-Kuang Wu, MD

Role: STUDY_DIRECTOR

Taichung Tzu Chi Hospital

Locations

Taipei Tzu Chi Hospital

New Taipei City, Xindan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chou-Chin Lan, MD, PHD

Role: CONTACT

bluescopy@yahoo.com.tw

800-555-5555 ext. 8119

Yao-Kuang Wu, MD

Role: CONTACT

drbfci@yahoo.com.tw

800-555-5555 ext. 2259

Facility Contacts

Chou-Chin Lan, MD

Role: primary

bluescopy@yahoo.com.tw

800-555-5555

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

10-XD-132

Identifier Type: -

Identifier Source: org_study_id