Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-30 @ 5:10 AM
Study NCT ID:
NCT06901557
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Jing-Si-Herbal-Tea in Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).\n\nThe UC group will receive standard medical treatment, with one placebo packet daily for three months.\n\nThe JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.\n\nThere were 12 participants in JSHT group and thirteen in UC group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life (HRQL)', 'timeFrame': 'The HRQL will be assessed at baseline and after three months of intervention.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiectasis'], 'conditions': ['Bronchiectasis']}, 'referencesModule': {'references': [{'pmid': '39234996', 'type': 'BACKGROUND', '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.'}, {'pmid': '39219819', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).\n\n* \\*\\*UC Group\\*\\*: Receives standard treatment and one placebo packet daily for three months.\n* \\*\\*JSHT Group\\*\\*: Receives standard treatment plus one packet of Jing-Si Herbal Tea daily for three months.\n\nEach 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.\n\n\\*\\*Assessments\\*\\*:\n\n* \\*\\*HRQL\\*\\*: Measured using the COPD Assessment Test (CAT) and the Modified Medical Research Council (mMRC) scale.\n* \\*\\*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.\n* \\*\\*Pulmonary Function Tests (PFT)\\*\\*: Conducted with a spirometer per American Thoracic Society guidelines.', 'detailedDescription': 'Patients are divided into two groups: the usual care group (UC group) and the Jing-Si Herbal Tea group (JSHT group).\n\nThe UC group will receive standard medical treatment, with one placebo packet daily for three months.\n\nThe JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.\n\nEach 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.\n\nBaseline 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.\n\nHealth-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.\n\nPulmonary function tests (PFT) PFT were conducted using a spirometer following the guidelines set by the American Thoracic Society.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Clinically diagnosed with bronchiectasis\n3. Willing to participate in the study\n4. Signed an informed consent form\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women\n2. Individuals with severe liver\n3. Individuals with severe kidney diseases\n4. Individuals who refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT06901557', 'acronym': 'JSHT-B', 'briefTitle': 'Benefits of Jing-Si-Herbal-Tea in Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation'}, 'officialTitle': 'Benefits of Jing-Si-Herbal-Tea in Bronchiectasis', 'orgStudyIdInfo': {'id': '12-XD-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'usual care group (UC group)', 'description': 'The UC group will receive standard medical treatment, with one placebo packet daily for three months.', 'interventionNames': ['Combination Product: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Jing-Si Herbal Tea group (JSHT group)', 'description': 'The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.', 'interventionNames': ['Combination Product: Jing-Si Herbal Tea']}], 'interventions': [{'name': 'Jing-Si Herbal Tea', 'type': 'COMBINATION_PRODUCT', 'description': 'The JSHT group will receive the standard medical treatment along with Jing-Si Herbal Tea, one packet daily for three months.', 'armGroupLabels': ['Jing-Si Herbal Tea group (JSHT group)']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'The UC group will receive standard medical treatment, with one placebo packet daily for three months.', 'armGroupLabels': ['usual care group (UC group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23142', 'city': 'New Taipei City', 'state': 'Xindan', 'country': 'Taiwan', 'facility': 'Taipei Tzu Chi Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Division of Pulmonary Medicine', 'investigatorFullName': 'Chou-Chin Lan', 'investigatorAffiliation': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation'}}}}