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Completed

NCT Number: NCT06901557

Benefits of Jing-Si-Herbal-Tea in Bronchiectasis

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Tzu Chi Hospital

New Taipei City, Xindan, 23142, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Combination Product

The UC group will receive standard medical treatment, with one placebo packet daily for three months.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Acronym: JSHT-B

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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