Cardiovascular Diseases, Gut Microbiome, Herbal Medicine, Inflammatory Response, Life Quality, Trimethylamine N-oxide
Conditions
Keywords
Jing Si herbal tea liquid packet, microbiome, trimethylamine N-oxide (TMAO), double-blind randomized controlled trial
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.
Interventions
DIETARY_SUPPLEMENTJing Si herbal tea liquid packet
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
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory biomarkers | 3 months | IL-1b (pg/mL), IL-4(pg/mL), IL-6(pg/mL), IL-10(pg/mL), TNF-gamma(pg/mL),TNF-alpha (pg/mL) |
| 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) |
| diabetes control index | 3 months | HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta |
| biomarkers for congestive heart failure | 3 months | Nt-proBNP (pg/ mL) |
| heart function measurement for congestive heart failure | 3 months | LVEF(%) |
| kidney function 1 | 3 months | BUN (mg/dL),Cre (mg/dL) |
| kidney function 2 | 3 months | eGFR (mL/min) |
| kidney function 3 | 3 months | Urine Albumin to Creatinine Ratio(mg/g) |
| Gut microbiome | 3 months | TMAO (uM) |
| immune composition analysis 1 | 3 months | CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%) |
| immune composition analysis 2 | 3 months | WBC (10\^3/uL) |
| immune function analysis | 3 months | IFN-gamma (IU/mL) |
Contacts
Primary ContactHuai-Ren Chang, M.D. PhD.
Outcome results
None listed