The Effects of JING SI HERBAL TEA LIQ UID PACKETS on Inflammation in Patients With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- diabetes control index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypertension,
- •hyperlipidemia,
- •ischemic heart disease
排除标准
- •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
结局指标
主要结局
diabetes control index
时间窗: 3 months
HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
kidney function 1
时间窗: 3 months
BUN (mg/dL),Cre (mg/dL)
heart function measurement for congestive heart failure
时间窗: 3 months
LVEF(%)
lipid profile , Glu-AC, hs_CRP
时间窗: 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
时间窗: 3 months
Urine Albumin to Creatinine Ratio(mg/g)
Gut microbiome
时间窗: 3 months
TMAO (uM)
immune composition analysis 2
时间窗: 3 months
WBC (10\^3/uL)
inflammatory biomarkers
时间窗: 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)
biomarkers for congestive heart failure
时间窗: 3 months
Nt-proBNP (pg/ mL)
kidney function 2
时间窗: 3 months
eGFR (mL/min)
immune composition analysis 1
时间窗: 3 months
CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
immune function analysis
时间窗: 3 months
IFN-gamma (IU/mL)
次要结局
未报告次要终点