An interventional study of Jing Si herbal tea liquid packet in Inflammatory Response, Gut Microbiome and Life Quality, sponsored by Buddhist Tzu Chi General Hospital. Status unknown. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by Buddhist Tzu Chi General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 928 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Jing Si herbal tea liquid packet
Dietary Supplement: Jing Si herbal tea liquid packet
Jing Si herbal tea placebo
Dietary Supplement: Jing 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
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)
Time frame: 3 months
inflammatory biomarkers
GlycA (umol/L)
Time frame: 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)
Time frame: 3 months
diabetes control index
HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
Time frame: 3 months
biomarkers for congestive heart failure
Nt-proBNP (pg/ mL)
Time frame: 3 months
heart function measurement for congestive heart failure
LVEF(%)
Time frame: 3 months
kidney function 1
BUN (mg/dL),Cre (mg/dL)
Time frame: 3 months
kidney function 2
eGFR (mL/min)
Time frame: 3 months
kidney function 3
Urine Albumin to Creatinine Ratio(mg/g)
Time frame: 3 months
Gut microbiome
TMAO (uM)
Time frame: 3 months
immune composition analysis 1
CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
Time frame: 3 months
immune composition analysis 2
WBC (10\^3/uL)
Time frame: 3 months
immune function analysis
IFN-gamma (IU/mL)
Time frame: 3 months
No study locations are listed for this record.
Plan to share: No — no, we are not going to share IPD.
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Buddhist Tzu Chi General Hospital