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

Study Overview
=================
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.

Official Title
-----------------
The Effects of JING SI HERBAL TEA LIQ UID PACKETS on Inflammation in Patients With Cardiovascular Disease

Conditions
-----------------
Inflammatory Response, Gut Microbiome, Life Quality, Trimethylamine N-oxide, Cardiovascular Diseases, Herbal Medicine

Intervention / Treatment
-----------------
* Dietary Supplement: Jing Si herbal tea liquid packet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active arm<br>Jing Si herbal tea liquid packet | Dietary Supplement: Jing Si herbal tea liquid packet<br>* 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<br>|
| Placebo Comparator: control arm<br>Jing Si herbal tea placebo | Dietary Supplement: Jing Si herbal tea liquid packet<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 
| inflammatory biomarkers | GlycA (umol/L) | 3 months | 
| 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) | 3 months | 
| diabetes control index | HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta | 3 months | 
| biomarkers for congestive heart failure | Nt-proBNP (pg/ mL) | 3 months | 
| heart function measurement for congestive heart failure | LVEF(%) | 3 months | 
| kidney function 1 | BUN (mg/dL),Cre (mg/dL) | 3 months | 
| kidney function 2 | eGFR (mL/min) | 3 months | 
| kidney function 3 | Urine Albumin to Creatinine Ratio(mg/g) | 3 months | 
| Gut microbiome | TMAO (uM) | 3 months | 
| immune composition analysis 1 | CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%) | 3 months | 
| immune composition analysis 2 | WBC (10^3/uL) | 3 months | 
| immune function analysis | IFN-gamma (IU/mL) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trimethylamine N-oxide (TMAO), double-blind randomized controlled trial, Jing Si herbal tea liquid packet, microbiome