The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink on Metabolism and Inflammation in Patients With Cardiovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The hematological parameter for systemic inflammation and stress
研究概览
简要总结
Through empirical research evaluating the effects of "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" as adjunctive treatments for various cardiovascular diseases, we aim to provide sufficient evidence to address the following questions:
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" significantly improve various inflammatory responses involved in the process of atherosclerosis, thereby enhancing the prognosis of patients with acute coronary syndrome and chronic ischemic heart disease?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" provide a healthy and effective adjunctive therapy for patients with hypertension, diabetes, and hyperlipidemia by lowering blood pressure (potentially related to known ACE2 receptors), blood glucose levels (including the improvement of pancreatic β-cell insulin secretion capacity and cellular insulin utilization efficiency), and cholesterol levels?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" influence the prognosis of various diseases, including the most critical cardiovascular conditions such as acute coronary syndrome and chronic ischemic heart disease, by altering the human gut microbiota?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" improve renal indicators such as BUN, creatinine, UACR, and eGFR, thereby protecting the kidneys and reducing complications like microalbuminuria?
详细描述
The Jing-Si Herbal Drink is composed of eight native Taiwanese herbal ingredients: mugwort, fishwort, houttuynia, dwarf lilyturf, balloon flower, perilla leaf, chrysanthemum, and licorice. These ingredients are known for their properties to clear heat, dispel cold, ventilate the lungs, transform phlegm, and eliminate dampness. Preliminary cell and animal studies have demonstrated that this drink can block the binding of the novel coronavirus (SARS-CoV-2) to cells and reduce cellular penetration, thereby preventing the virus from entering the cells. Recently, the Jing-Si Herbal Drink in powder form, known as "Jing-Si Herbal Drink Concentrate Powder," received an export-specific license from the Ministry of Health and Welfare. A research team from Taipei Tzu Chi Hospital has confirmed that combining standard treatment with Jing-Si Herbal Drink provides good clinical protective effects and safety for patients with mild to moderate COVID-19.
Angiotensin-converting enzyme 2 (ACE2), encoded by the ACE2 gene located on the X chromosome, regulates blood pressure and endocrine functions by clearing the vasopressor angiotensin II (Ang II), thereby allowing blood vessels to relax. Studies have shown that the human ACE2 receptor is the gateway for the novel coronavirus (SARS-CoV-2) to enter cells. Both the novel coronavirus and the SARS coronavirus must bind to the ACE2 receptor via their spike proteins to enter cells and replicate extensively, leading to pathogenicity. It is therefore reasonable to hypothesize that the Jing-Si Herbal Drink may block the binding of the novel coronavirus (SARS-CoV-2) to cells by regulating the ACE2 receptor.
Recently, the basic medical research team on herbal drinks at Hualien Tzu Chi Hospital has demonstrated through animal experiments that the Jing-Si Herbal Drink has significant anti-aging protective effects on cardiovascular and metabolic functions in aged rats (24-month-old WKY rats). Additionally, a preliminary analysis conducted by Professor Hong-Chih Han's laboratory at the Hualien Tzu Chi Hospital's Innovation and Research Center revealed that various aspects of immune function were positively affected by the Jing-Si Herbal Drink. It was observed that IFN-γ levels in the blood of subjects significantly increased 48-96 hours after consumption of the Jing-Si Herbal Drink, suggesting that it plays an important role in immune regulation.
The Jing-Si Abode Herbal Research and Development Team has built upon the original Jing-Si Herbal Drink formula to create a new generation of herbal beverage: Jing-Si Herbal Sugar-Balance Beverage. This new formula incorporates pumpkin powder and bitter melon extract powder (containing bitter melon peptides) in addition to the eight original herbal ingredients of the concentrated herbal drink. It is expected to provide enhanced protection for blood sugar and lipid metabolism as well as immune function. Recently, the basic medical research team on herbal drinks at Hualien Tzu Chi Hospital conducted animal experiments that preliminarily confirmed the superior blood sugar-lowering effects of the Jing-Si Herbal Sugar-Balance Beverage formula in diabetic rats compared to the original Jing-Si Herbal Drink formula and the drug Metformin.
The investigators will leverage the professional care provided by clinical physicians and the analytical research capabilities of our basic laboratory to collaboratively evaluate the effects of "Jing-Si Herbal Drink Concentrate" and "Jing-Si Herbal Drink Sugar-Balance Beverage" as adjunctive treatments for patients with various cardiovascular diseases. The investigators aim to not only improve the quality of life for these patients but also achieve beneficial outcomes in treating some clinically challenging diseases and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age 20-75 years.
- •Diagnosed with any of the following diseases:
- •(1) Hypertension (2) Hyperlipidemia (3) Diabetes (4) Ischemic heart disease"
排除标准
- •History of cancer.
- •Subjects with severe or poorly controlled chronic diseases as determined by the principal investigator.
- •Poor renal function (eGFR <40 ml/min/1.73m²).
- •Pregnant or breastfeeding at the time of screening.
结局指标
主要结局
The hematological parameter for systemic inflammation and stress
时间窗: Baseline, 4 and 12 weeks after each intervention is given.
neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio
Effect of intervention on lipid profile
时间窗: Baseline, 4 and 12 weeks after intervention is given.
TCH、TG、HDL-C、LDL-C
Long term blood sugar status
时间窗: Baseline, 4 and 12 weeks after intervention is given.
HbA1C
To evaluate the metabolic health
时间窗: Baseline, 4 and 12 weeks after intervention is given.
Uric acid
Effect of blood uric acid on Cardiovascular Disease and body inflammation status
时间窗: Baseline, 4 and 12 weeks after intervention is given.
Uric acid
Homeostatic model assessment (HOMA) of insulin resistance
时间窗: Baseline, 4 and 12 weeks after intervention is given.
HOMA-IR is calculated by insulin level and Glu-AC
Inflammation biomarkers
时间窗: Baseline, 4 and 12 weeks after each intervention is given.
hs-C-reactive protein
Liver function
时间窗: Baseline, 4 and 12 weeks after each intervention is given
GOT、GPT
Effect of intervention on fasting sugar
时间窗: Baseline, 4 and 12 weeks after intervention is given.
Glu-AC
To evaluate the distribution of body fat
时间窗: Baseline, 4 and 12 weeks after each intervention is given
Waist-to-Hip Ratio
Evaluate the immune system function
时间窗: Baseline, 4 and 12 weeks after each intervention is given
CD3、CD4、CD8、CD56
Assessment of leukocyte activation
时间窗: Baseline, 4 and 12 weeks after each intervention is given
CD11b
Marker of inflammation
时间窗: Baseline, 4 and 12 weeks after each intervention is given
TNF-alpha
Analysis of Gut Microbiota in Stool Samples Using 16S rRNA Sequencing
时间窗: Stool samples will be collected at baseline (prior to intervention) and at 12 months post-intervention to assess changes in gut microbiota composition and abundance.
This study aims to analyze the gut microbiota in stool samples to assess changes in microbial composition and abundance following the intervention. The primary objective is to determine if the intervention lead to significant shifts in the diversity and relative proportions of gut bacteria
proinflammtory marker
时间窗: Baseline, 4 and 12 weeks after each intervention is given.
Glyc-A
Kidney function
时间窗: Baseline, 4 and 12 weeks after each intervention is given
BUN、Cre、eGFR(Calculated by age and Cre)
The concentration of the product of gut microbiome
时间窗: Baseline, 4 and 12 weeks after each intervention is given
SCFA (short-chain fatty acid)
Evaluation of activity of gut microbiome
时间窗: Baseline, 4 and 12 weeks after each intervention is given
TMA、TMAO
Body fat composition
时间窗: Baseline, 4 and 12 weeks after each intervention is given
BMI(calculated y weight and height)
To evaluates the body's ability to fight tumors and infections.
时间窗: Baseline, 4 and 12 weeks after each intervention is given
NK cells
Effect of intervention on blood pressure control
时间窗: Baseline, 4 and 12 weeks after each intervention is given
blood pressure
Measurement of overall immune function and response to infection or inflammation
时间窗: Baseline, 4 and 12 weeks after each intervention is given
WBC
To assess immune activation and the ability to present antigens to T cells
时间窗: Baseline, 4 and 12 weeks after each intervention is given
HLA-DR
Assessment of immune response
时间窗: Baseline, 4 and 12 weeks after each intervention is given
IFN-gamma、IL-6
次要结局
未报告次要终点
研究者
Chang Huai Ren
Principal Investigator
Buddhist Tzu Chi General Hospital