Benefits of Jing-Si-Herbal-Tea in Bronchiectasis

NCT ID: NCT06901557

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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).

* \*\*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

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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.

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.

Conditions

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Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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usual care group (UC group)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type EXPERIMENTAL

Jing-Si Herbal Tea

Intervention Type COMBINATION_PRODUCT

The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.

Interventions

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Jing-Si Herbal Tea

The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.

Intervention Type COMBINATION_PRODUCT

Placebo

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Chou-Chin Lan

Head of Division of Pulmonary Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Tzu Chi Hospital

New Taipei City, Xindan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 39234996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39219819 (View on PubMed)

Other Identifiers

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12-XD-053

Identifier Type: -

Identifier Source: org_study_id

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