Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease
- Conditions
- Inflammatory ResponseCardiovascular DiseasesGut MicrobiomeLife QualityTrimethylamine N-oxideHerbal Medicine
- Interventions
- Dietary Supplement: Jing Si herbal tea liquid packet
- Registration Number
- NCT05420987
- Lead Sponsor
- Buddhist Tzu Chi General Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- hypertension,
- hyperlipidemia,
- ischemic heart disease
- diabetes
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active arm Jing Si herbal tea liquid packet Jing Si herbal tea liquid packet control arm Jing Si herbal tea liquid packet Jing Si herbal tea placebo
- Primary Outcome Measures
Name Time Method kidney function 2 3 months eGFR (mL/min)
immune composition analysis 1 3 months CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
diabetes control index 3 months HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
heart function measurement for congestive heart failure 3 months LVEF(%)
kidney function 1 3 months BUN (mg/dL),Cre (mg/dL)
lipid profile , Glu-AC, hs_CRP 3 months 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)
kidney function 3 3 months Urine Albumin to Creatinine Ratio(mg/g)
Gut microbiome 3 months TMAO (uM)
immune composition analysis 2 3 months WBC (10\^3/uL)
inflammatory biomarkers 3 months GlycA (umol/L)
biomarkers for congestive heart failure 3 months Nt-proBNP (pg/ mL)
immune function analysis 3 months IFN-gamma (IU/mL)
- Secondary Outcome Measures
Name Time Method