NCT06901557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

September 9, 2024

Last Update Submit

March 27, 2025

Conditions

Bronchiectasis

Keywords

bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    The HRQL will be assessed at baseline and after three months of intervention.

Study Arms (2)

usual care group (UC group)

PLACEBO COMPARATOR

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

Combination Product: Placebo

Jing-Si Herbal Tea group (JSHT group)

EXPERIMENTAL

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

Combination Product: Jing-Si Herbal Tea

Interventions

Jing-Si Herbal TeaCOMBINATION_PRODUCT

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

Jing-Si Herbal Tea group (JSHT group)
PlaceboCOMBINATION_PRODUCT

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

usual care group (UC group)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Clinically diagnosed with bronchiectasis
  • Willing to participate in the study
  • Signed an informed consent form

You may not qualify if:

  • Pregnant or breastfeeding women
  • Individuals with severe liver
  • Individuals with severe kidney diseases
  • Individuals who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Xindan, 23142, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 39234996BACKGROUND

  • 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.

    PMID: 39219819BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Division of Pulmonary Medicine

Study Record Dates

First Submitted

September 9, 2024

First Posted

March 30, 2025

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The investigators have decided not to share individual participant data (IPD) due to several important considerations. Protecting participant privacy is our top priority, as sharing IPD could expose sensitive personal information and pose risks of re-identification, even if de-identified. Additionally, participants did not consent to their data being shared with other researchers, and obtaining re-consent would be challenging. Ensuring data security also requires significant resources and technical measures that our current infrastructure may not support. Furthermore, complying with complex legal and ethical regulations surrounding data sharing adds another layer of complexity. Finally, maintaining the quality and integrity of IPD before sharing demands extra effort and resources. These factors collectively influence our decision to prioritize participant protection and data security.

Locations

TW(1)