Therapeutic Effects of Jing Si Herbal Tea for COPD

Therapeutic Effects of Jing Si Herbal Tea for Chronic Obstructive Pulmonary Disease: A Comprehensive Investigation From Clinical to Basic Research

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Disease
• Intervention / Treatment: Other: Placebo; Combination product: Jing Si herbal tea (JSHT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chou-Chin Lan, MD, PHD; Phone Number: 8119 800-555-5555; Email: bluescopy@yahoo.com.tw
• Study Contact Backup: Name: Yao-Kuang Wu, MD; Phone Number: 2259 800-555-5555; Email: drbfci@yahoo.com.tw

Study Locations

• Taiwan
  • Xindan
    • New Taipei City, Xindan, Taiwan, 23142
      • Recruiting
      • Taipei Tzu Chi Hospital
      • Contact: Chou-Chin Lan, MD; Phone Number: 800-555-5555; Email: bluescopy@yahoo.com.tw
      • Principal Investigator: Chou-Chin Lan, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• COPD patients willing to enter this study

Exclusion Criteria:

• not COPD patients, no willing to enter this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group (1); Placebo group: participants with COPD AE is treated with placebo that mimic JSHT	Other: Placebo; Placebo of JSHT; Other Names: Placebo of JSHT
Placebo Comparator: Placebo group (2); participants with stable COPD treated with placebo that mimic JSHT	Other: Placebo; Placebo of JSHT; Other Names: Placebo of JSHT
Experimental: JSHT group of stable COPD; participants with stable COPD treated with JSHT	Combination product: Jing Si herbal tea (JSHT); JSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635).
Experimental: JSHT group of COPDAE; participants with COPD AE is treated with JSHT	Combination product: Jing Si herbal tea (JSHT); JSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test (CAT)	The Taiwan Society of Pulmonary and Critical Care Medicine offers the Chinese version of the COPD Assessment Test (CAT) on the website (http://tspccm.org.tw). This test consists of eight items designed to evaluate COPD symptoms. These symptoms include cough, phlegm production, chest tightness, breathlessness, limitations in daily activities, confidence in leaving the house, sleep disturbances, and energy levels. Each symptom is rated on a scale from 0 to 5, culminating in a total CAT score ranging from 0 to 40. A higher score reflects more severe COPD symptoms. A score of 10 or higher is indicative of a significant symptom burden.	Assess at baseline and three months of treatment
Modified Medical Research Council (mMRC)	The Modified Medical Research Council (mMRC) scale was used to evaluate dyspnea. This scale, comprising a 5-point grading system ranging from 0 to 4, measures dyspnea severity. A score of 0 indicates dyspnea only during intense exercise, while a sore of 4 represents breathlessness at rest.	Assess at baseline and three months of treatment
Brief Symptom Rating Scale (BSRS-5)	The 5-item Brief Symptom Rating Scale (BSRS-5) was used to assess psychological distress. It consists of five items: feeling tense, being easily angered, feeling depressed, feeling inferior to others, difficulty with sleep, and suicidal thoughts. The scale is a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms.	Assess at baseline and three months of treatment

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Principal Investigator: Chou-Chin Lan, MD, Taichung Tzu Chi Hospital; Study Director: Yao-Kuang Wu, MD, Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: COPD; damage-associated molecular patterns; Jing Si herbal tea
• Other Study ID Numbers: 10-XD-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research is ongoing and not suitable for publication in order to protect intellectual property.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No