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
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
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
NCT ID
NCT05420987
First Posted
May 29, 2022
Last Updated
June 12, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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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