Benefits of Jing-Si-Herbal-Tea in Bronchiectasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Health-related quality of life (HRQL)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Clinically diagnosed with bronchiectasis
- •Willing to participate in the study
- •Signed an informed consent form
Exclusion Criteria
- •Pregnant or breastfeeding women
- •Individuals with severe liver
- •Individuals with severe kidney diseases
- •Individuals who refuse to participate in the study
Arms & Interventions
usual care group (UC group)
The UC group will receive standard medical treatment, with one placebo packet daily for three months.
Intervention: Placebo (Combination Product)
Jing-Si Herbal Tea group (JSHT group)
The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.
Intervention: Jing-Si Herbal Tea (Combination Product)
Outcomes
Primary Outcomes
Health-related quality of life (HRQL)
Time Frame: The HRQL will be assessed at baseline and after three months of intervention.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chou-Chin Lan
Head of Division of Pulmonary Medicine
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation