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Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).
Each group includes 30 participants. The study runs from January 1, 2014, to December 31, 2014. Exclusions include severe liver or renal dysfunction and allergy to Jing-Si Herbal Tea. Participants must follow the study protocol.
**Assessments**:
Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).
The UC group will receive standard medical treatment, with one placebo packet daily for three months.
The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.
Each group will enroll 30 participants. Study period: From January 1, 2014, to December 31, 2014. During the study, participants with contraindications such as severe liver dysfunction, severe renal dysfunction, or a history of allergy to JSHT are excluded from enrollment based on the exclusion criteria at the time of enrollment. The only requirement for participants is to adhere to the study protocol regarding the consumption of JSHT and undergoing tests.
Baseline and post-treatment HRQL were assessed using the COPD assessment test (CAT), along with blood tests including white blood cells (WBCs), percentages of different types of WBCs (neutrophils, lymphocytes, monocytes, eosinophils, basophils), hemoglobin (Hb), hematocrit (Hct), platelets (PLT), blood urea nitrogen (BUN), creatinine (Cr), uric acid (UA), liver enzymes (aspartate aminotransferase, alanine aminotransferase), electrolytes (sodium, potassium), C-reactive protein (CRP), and pro-brain natriuretic peptide (pPro-BNP). Blood samples from patients will be analyzed for DAMPs and inflammatory cytokines.
Health-related quality of life (HRQL) The Taiwan Society of Pulmonary and Critical Care Medicine offers the Chinese version of the COPD Assessment Test (CAT) on the website. 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. 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.
Pulmonary function tests (PFT) PFT were conducted using a spirometer following the guidelines set by the American Thoracic Society.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care group (UC group) | Placebo Comparator | The UC group will receive standard medical treatment, with one placebo packet daily for three months. |
|
| Jing-Si Herbal Tea group (JSHT group) | Experimental | The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jing-Si Herbal Tea | Combination Product | The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (HRQL) | The Taiwan Society of Pulmonary and Critical Care Medicine offers the Chinese version of the COPD Assessment Test (CAT) on the website. 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. 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. | The HRQL will be assessed at baseline and after three months of intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | New Taipei City | Xindan | 23142 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39234996 | Background | Kao SW, Chang YC, Lin FH, Huang TL, Chen TS, Lin SZ, Lin KH, Kuo WW, Ho TJ, Huang CY. Jing-Si Herbal Tea Suppresses H2O2 -Instigated Inflammation and Apoptosis by Inhibiting Bax and Mitochondrial Cytochrome C Release in HIG-82 Synoviocytes. Environ Toxicol. 2024 Dec;39(12):5347-5356. doi: 10.1002/tox.24406. Epub 2024 Sep 5. | |
| 39219819 |
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The investigators have decided not to share individual participant data (IPD) due to several important considerations. Protecting participant privacy is our top priority, as sharing IPD could expose sensitive personal information and pose risks of re-identification, even if de-identified. Additionally, participants did not consent to their data being shared with other researchers, and obtaining re-consent would be challenging. Ensuring data security also requires significant resources and technical measures that our current infrastructure may not support. Furthermore, complying with complex legal and ethical regulations surrounding data sharing adds another layer of complexity. Finally, maintaining the quality and integrity of IPD before sharing demands extra effort and resources. These factors collectively influence our decision to prioritize participant protection and data security.
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).
The UC group will receive standard medical treatment, with one placebo packet daily for three months.
The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.
There were 12 participants in JSHT group and thirteen in UC group.
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| Placebo | Combination Product | The UC group will receive standard medical treatment, with one placebo packet daily for three months. |
|
| Lin HC, Hsieh MH, Lo YL, Huang HY, Huang SW, Huang CD, Chang PJ, Lo CY, Lin TY, Fang YF, Lin SM, Lin CY, Tsai YH. IL-6 and TIMP-1 Correlated to Airway Pathogen Colonization and Predict Disease Severity in Patients with Non-Cystic Fibrosis Bronchiectasis. J Inflamm Res. 2024 Aug 28;17:5701-5709. doi: 10.2147/JIR.S465413. eCollection 2024. |