Clinical trial NCT06901557: Benefits of Jing-Si-Herbal-Tea in Bronchiectasis
Official title: Benefits of Jing-Si-Herbal-Tea in Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: bronchiectasis
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.

There were 12 participants in JSHT group and thirteen in UC group.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Clinically diagnosed with bronchiectasis
3. Willing to participate in the study
4. Signed an informed consent form

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Individuals with severe liver
3. Individuals with severe kidney diseases
4. Individuals who refuse to participate in the study

Primary outcomes:
measure: Health-related quality of life (HRQL)
timeFrame: The HRQL will be assessed at baseline and after three months of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
state: Xindan
Study officials:
References:
citation: 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.
citation: 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.