Therapeutic Effects of Jing Si Herbal Tea for COPD

NCT06584786 | Recruiting Early Phase 1

• 1 other identifier: 10-XD-132
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Disease

Keywords

COPD; Jing Si herbal tea; damage-associated molecular patterns

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Placebo group (1)

PLACEBO COMPARATOR

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

Other: Placebo

Placebo group (2)

PLACEBO COMPARATOR

participants with stable COPD treated with placebo that mimic JSHT

Other: Placebo

JSHT group of stable COPD

EXPERIMENTAL

participants with stable COPD treated with JSHT

Combination Product: Jing Si herbal tea (JSHT)

JSHT group of COPDAE

EXPERIMENTAL

participants with COPD AE is treated with JSHT

Combination Product: Jing Si herbal tea (JSHT)

Interventions

Jing Si herbal tea (JSHT) COMBINATION_PRODUCT

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

JSHT group of COPDAE; JSHT group of stable COPD

Placebo OTHER

Placebo of JSHT

Also known as: Placebo of JSHT

Placebo group (1); Placebo group (2)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients willing to enter this study

You may not qualify if:

• not COPD patients, no willing to enter this study

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Xindan, 23142, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chou-Chin Lan, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

• Yao-Kuang Wu, MD

  Taichung Tzu Chi Hospital

  STUDY DIRECTOR

Central Study Contacts

Chou-Chin Lan, MD, PHD

CONTACT

800-555-5555; bluescopy@yahoo.com.tw

Yao-Kuang Wu, MD

CONTACT

800-555-5555; drbfci@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: September 5, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)