Airway DiseaseEarly Phase 1NCT06584786
Therapeutic Effects of Jing Si Herbal Tea for COPD
A Early Phase 1 study testing Jing Si herbal tea (JSHT) in people with Airway Disease, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Airway Disease
- What is being tested?
- Jing Si herbal tea (JSHT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients willing to enter this study
Who cannot join
- not COPD patients, no willing to enter this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City, Xindan, 23142
Chou-Chin Lan, MD, 800-555-5555, bluescopy@yahoo.com.tw
Chou-Chin Lan, MD, PHD
About this study
Official title: 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.
Read the 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
- Being tested
- Jing Si herbal tea (JSHT), Placebo
- Keywords
- COPD, Jing Si herbal tea, damage-associated molecular patterns
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
PlaceboOther
Also called Placebo of JSHT
Placebo of JSHT
| Study group | Role | What they receive |
|---|---|---|
| Placebo group (1) | Placebo comparator | Placebo group: participants with COPD AE is treated with placebo that mimic JSHT Receives: Other: Placebo |
| Placebo group (2) | Placebo comparator | participants with stable COPD treated with placebo that mimic JSHT Receives: Other: Placebo |
| JSHT group of stable COPD | Experimental | participants with stable COPD treated with JSHT Receives: Combination Product: Jing Si herbal tea (JSHT) |
| JSHT group of COPDAE | Experimental | participants with COPD AE is treated with JSHT Receives: Combination Product: Jing Si herbal tea (JSHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assess at baseline and three months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chou-Chin Lan, MD, Principal investigator, Taichung Tzu Chi HospitalYao-Kuang Wu, MD, Study director, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584786
- Sponsor's protocol ID
- 10-XD-132
- Status last verified
- Sep 2024
- First submitted
- 2 Apr 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research is ongoing and not suitable for publication in order to protect intellectual property.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Jing Si Herbal Tea for Chronic Obstructive Pulmonary Disease: A Comprehensive Investigation From Clinical to Basic Research
- ClinicalTrials.gov ID
- NCT06584786
- Acronym / sponsor ID
- 10-XD-132
- Conditions
- Airway Disease
- Keywords
- COPD, Jing Si herbal tea, damage-associated molecular patterns
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo group (1) | Placebo comparator | Other: PlaceboPlacebo group: participants with COPD AE is treated with placebo that mimic JSHT |
| Placebo group (2) | Placebo comparator | Other: Placeboparticipants with stable COPD treated with placebo that mimic JSHT |
| JSHT group of stable COPD | Experimental | Combination Product: Jing Si herbal tea (JSHT)participants with stable COPD treated with JSHT |
| JSHT group of COPDAE | Experimental | Combination Product: Jing Si herbal tea (JSHT)participants with COPD AE is treated with JSHT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients willing to enter this study
Key exclusion criteria (1 listed)
- not COPD patients, no willing to enter this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing Si herbal tea (JSHT)JSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635). | Combination product | JSHT group of COPDAE, JSHT group of stable COPD |
| PlaceboAlso: Placebo of JSHTPlacebo of JSHT | Other | Placebo group (1), Placebo group (2) |
Primary outcome
COPD Assessment Test (CAT)
Time frame: Assess at baseline and three months of treatment
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.
Modified Medical Research Council (mMRC)
Time frame: Assess at baseline and three months of treatment
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.
Brief Symptom Rating Scale (BSRS-5)
Time frame: Assess at baseline and three months of treatment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No. The research is ongoing and not suitable for publication in order to protect intellectual property.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chou-Chin Lan, MD principal investigator
Taichung Tzu Chi Hospital
Yao-Kuang Wu, MD study director
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Jing Si herbal tea (JSHT) in people with Airway Disease, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chou-Chin Lan, MD, PHD (800-555-5555 ext. 8119, bluescopy@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test (CAT) (time frame: Assess at baseline and three months of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.