The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink
- Conditions
- Trimethylamine N-oxideInflammatory MarkerHbA1cAtherosclerosisGut Microbiome
- Interventions
- Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETSDietary Supplement: JING SI HERBAL TANG HENG POWDER DRINK
- Registration Number
- NCT06522412
- Lead Sponsor
- Buddhist Tzu Chi General Hospital
- Brief Summary
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:
1. 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?
2. 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?
3. 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?
4. 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?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age 20-75 years.
- Diagnosed with any of the following diseases:
(1) Hypertension (2) Hyperlipidemia (3) Diabetes (4) Ischemic heart disease"
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TL_TH JING SI HERBAL TEA LIQUID PACKETS The participants takeJING SI HERBAL TEA LIQUID PACKETS first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TANG HENG POWDER DRINK for 12 weeks. TH_TL JING SI HERBAL TEA LIQUID PACKETS The participants take JING SI HERBAL TANG HENG POWDER DRINK first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TEA LIQUID PACKETS for 12 weeks. TL_TH JING SI HERBAL TANG HENG POWDER DRINK The participants takeJING SI HERBAL TEA LIQUID PACKETS first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TANG HENG POWDER DRINK for 12 weeks. TH_TL JING SI HERBAL TANG HENG POWDER DRINK The participants take JING SI HERBAL TANG HENG POWDER DRINK first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TEA LIQUID PACKETS for 12 weeks.
- Primary Outcome Measures
Name Time Method Effect of blood uric acid on Cardiovascular Disease and body inflammation status Baseline, 4 and 12 weeks after intervention is given. Uric acid
The hematological parameter for systemic inflammation and stress Baseline, 4 and 12 weeks after each intervention is given. neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio
Effect of intervention on lipid profile Baseline, 4 and 12 weeks after intervention is given. TCH、TG、HDL-C、LDL-C
Long term blood sugar status Baseline, 4 and 12 weeks after intervention is given. HbA1C
Homeostatic model assessment (HOMA) of insulin resistance Baseline, 4 and 12 weeks after intervention is given. HOMA-IR is calculated by insulin level and Glu-AC
Inflammation biomarkers Baseline, 4 and 12 weeks after each intervention is given. hs-C-reactive protein
Liver function Baseline, 4 and 12 weeks after each intervention is given GOT、GPT
Effect of intervention on fasting sugar Baseline, 4 and 12 weeks after intervention is given. Glu-AC
To evaluate the metabolic health Baseline, 4 and 12 weeks after intervention is given. Uric acid
To evaluate the distribution of body fat Baseline, 4 and 12 weeks after each intervention is given Waist-to-Hip Ratio
Evaluate the immune system function Baseline, 4 and 12 weeks after each intervention is given CD3、CD4、CD8、CD56
Assessment of leukocyte activation Baseline, 4 and 12 weeks after each intervention is given CD11b
Marker of inflammation Baseline, 4 and 12 weeks after each intervention is given TNF-alpha
Analysis of Gut Microbiota in Stool Samples Using 16S rRNA Sequencing 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 Baseline, 4 and 12 weeks after each intervention is given. Glyc-A
Kidney function 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 Baseline, 4 and 12 weeks after each intervention is given SCFA (short-chain fatty acid)
Evaluation of activity of gut microbiome Baseline, 4 and 12 weeks after each intervention is given TMA、TMAO
Body fat composition 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. Baseline, 4 and 12 weeks after each intervention is given NK cells
Effect of intervention on blood pressure control Baseline, 4 and 12 weeks after each intervention is given blood pressure
Measurement of overall immune function and response to infection or inflammation Baseline, 4 and 12 weeks after each intervention is given WBC
To assess immune activation and the ability to present antigens to T cells Baseline, 4 and 12 weeks after each intervention is given HLA-DR
Assessment of immune response Baseline, 4 and 12 weeks after each intervention is given IFN-gamma、IL-6
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hualien Tzu Chi Hospital
🇨🇳Hualien City, Taiwan