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Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease

Primary Purpose

Inflammatory Response, Gut Microbiome, Life Quality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Jing Si herbal tea liquid packet
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Response focused on measuring Jing Si herbal tea liquid packet, microbiome, trimethylamine N-oxide (TMAO), double-blind randomized controlled trial

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hypertension,
  • hyperlipidemia,
  • ischemic heart disease
  • diabetes

Exclusion Criteria:

  • cancer patients,
  • have comorbidities with poor control
  • patients with eGFR< 40 ml/min/1.73m2
  • who are pregnant, breastfeeding, and in their menstrual period when recruiting

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    active arm

    control arm

    Arm Description

    Jing Si herbal tea liquid packet

    Jing Si herbal tea placebo

    Outcomes

    Primary Outcome Measures

    inflammatory biomarkers
    IL-1b (pg/mL), IL-4(pg/mL), IL-6(pg/mL), IL-10(pg/mL), TNF-gamma(pg/mL),TNF-alpha (pg/mL)
    inflammatory biomarkers
    GlycA (umol/L)
    lipid profile , Glu-AC, hs_CRP
    Total cholesterol(mg/dL), TG(mg/dL), HDL-C(mg/dL), LDL-C(mg/dL), uric acid (mg/dL) and Glu-AC (mg/dL),hs_CRP(mg/dL)
    diabetes control index
    HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
    biomarkers for congestive heart failure
    Nt-proBNP (pg/ mL)
    heart function measurement for congestive heart failure
    LVEF(%)
    kidney function 1
    BUN (mg/dL),Cre (mg/dL)
    kidney function 2
    eGFR (mL/min)
    kidney function 3
    Urine Albumin to Creatinine Ratio(mg/g)
    Gut microbiome
    TMAO (uM)
    immune composition analysis 1
    CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
    immune composition analysis 2
    WBC (10^3/uL)
    immune function analysis
    IFN-gamma (IU/mL)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 29, 2022
    Last Updated
    June 12, 2022
    Sponsor
    Buddhist Tzu Chi General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05420987
    Brief Title
    Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease
    Official Title
    The Effects of JING SI HERBAL TEA LIQ UID PACKETS on Inflammation in Patients With Cardiovascular Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Buddhist Tzu Chi General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan. The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change. We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting. The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.
    Detailed Description
    Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan. The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change. We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting. The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm. All the patients' specimens and questionnaires are going to be collected on Day0, Day28, and Day84.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Response, Gut Microbiome, Life Quality, Trimethylamine N-oxide, Cardiovascular Diseases, Herbal Medicine
    Keywords
    Jing Si herbal tea liquid packet, microbiome, trimethylamine N-oxide (TMAO), double-blind randomized controlled trial

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    active arm
    Arm Type
    Experimental
    Arm Description
    Jing Si herbal tea liquid packet
    Arm Title
    control arm
    Arm Type
    Placebo Comparator
    Arm Description
    Jing Si herbal tea placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Jing Si herbal tea liquid packet
    Intervention Description
    Jing Si herbal tea includes eight Taiwan native-grown herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice
    Primary Outcome Measure Information:
    Title
    inflammatory biomarkers
    Description
    IL-1b (pg/mL), IL-4(pg/mL), IL-6(pg/mL), IL-10(pg/mL), TNF-gamma(pg/mL),TNF-alpha (pg/mL)
    Time Frame
    3 months
    Title
    inflammatory biomarkers
    Description
    GlycA (umol/L)
    Time Frame
    3 months
    Title
    lipid profile , Glu-AC, hs_CRP
    Description
    Total cholesterol(mg/dL), TG(mg/dL), HDL-C(mg/dL), LDL-C(mg/dL), uric acid (mg/dL) and Glu-AC (mg/dL),hs_CRP(mg/dL)
    Time Frame
    3 months
    Title
    diabetes control index
    Description
    HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
    Time Frame
    3 months
    Title
    biomarkers for congestive heart failure
    Description
    Nt-proBNP (pg/ mL)
    Time Frame
    3 months
    Title
    heart function measurement for congestive heart failure
    Description
    LVEF(%)
    Time Frame
    3 months
    Title
    kidney function 1
    Description
    BUN (mg/dL),Cre (mg/dL)
    Time Frame
    3 months
    Title
    kidney function 2
    Description
    eGFR (mL/min)
    Time Frame
    3 months
    Title
    kidney function 3
    Description
    Urine Albumin to Creatinine Ratio(mg/g)
    Time Frame
    3 months
    Title
    Gut microbiome
    Description
    TMAO (uM)
    Time Frame
    3 months
    Title
    immune composition analysis 1
    Description
    CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
    Time Frame
    3 months
    Title
    immune composition analysis 2
    Description
    WBC (10^3/uL)
    Time Frame
    3 months
    Title
    immune function analysis
    Description
    IFN-gamma (IU/mL)
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hypertension, hyperlipidemia, ischemic heart disease diabetes Exclusion Criteria: cancer patients, have comorbidities with poor control patients with eGFR< 40 ml/min/1.73m2 who are pregnant, breastfeeding, and in their menstrual period when recruiting
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huai-Ren Chang, M.D. PhD.
    Phone
    03-8561825
    Ext
    10290
    Email
    8311016@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no, we are not going to share IPD.

    Learn more about this trial

    Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease

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