Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-30 @ 5:10 AM
Study NCT ID:
NCT06901557
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Jing-Si-Herbal-Tea in Bronchiectasis
Sponsor:
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Organization:
Study Overview
Official Title:
Benefits of Jing-Si-Herbal-Tea in Bronchiectasis
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JSHT-B
Brief Summary:
Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).
* \*\*UC Group\*\*: Receives standard treatment and one placebo packet daily for three months.
* \*\*JSHT Group\*\*: Receives standard treatment plus one packet of Jing-Si Herbal Tea daily for three months.
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\*\*:
* \*\*HRQL\*\*: Measured using the COPD Assessment Test (CAT) and the Modified Medical Research Council (mMRC) scale.
* \*\*Blood Tests\*\*: Include WBCs, hemoglobin, hematocrit, platelets, BUN, creatinine, uric acid, liver enzymes, electrolytes, CRP, and pPro-BNP. Blood samples will also be analyzed for DAMPs and inflammatory cytokines.
* \*\*Pulmonary Function Tests (PFT)\*\*: Conducted with a spirometer per American Thoracic Society guidelines.
* \*\*UC Group\*\*: Receives standard treatment and one placebo packet daily for three months.
* \*\*JSHT Group\*\*: Receives standard treatment plus one packet of Jing-Si Herbal Tea daily for three months.
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\*\*:
* \*\*HRQL\*\*: Measured using the COPD Assessment Test (CAT) and the Modified Medical Research Council (mMRC) scale.
* \*\*Blood Tests\*\*: Include WBCs, hemoglobin, hematocrit, platelets, BUN, creatinine, uric acid, liver enzymes, electrolytes, CRP, and pPro-BNP. Blood samples will also be analyzed for DAMPs and inflammatory cytokines.
* \*\*Pulmonary Function Tests (PFT)\*\*: Conducted with a spirometer per American Thoracic Society guidelines.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: