The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink
NCT Number: NCT06522412
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Marker|Gut Microbiome|Trimethylamine N-oxide|HbA1c|Atherosclerosis
Interventions: DIETARY_SUPPLEMENT: JING SI HERBAL TEA LIQUID PACKETS|DIETARY_SUPPLEMENT: JING SI HERBAL TANG HENG POWDER DRINK
Sponsor: Buddhist Tzu Chi General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-01
Completion Date: 2026-12
Locations: Hualien Tzu Chi Hospital, Hualien City, Taiwan

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?

Primary Outcome Measures: Effect of intervention on lipid profile, TCH、TG、HDL-C、LDL-C, Baseline, 4 and 12 weeks after intervention is given.|Effect of blood uric acid on Cardiovascular Disease and body inflammation status, Uric acid, Baseline, 4 and 12 weeks after intervention is given.|Effect of intervention on fasting sugar, Glu-AC, Baseline, 4 and 12 weeks after intervention is given.|To evaluate the metabolic health, Uric acid, Baseline, 4 and 12 weeks after intervention is given.|Long term blood sugar status, HbA1C, Baseline, 4 and 12 weeks after intervention is given.|Homeostatic model assessment (HOMA) of insulin resistance, HOMA-IR is calculated by insulin level and Glu-AC, Baseline, 4 and 12 weeks after intervention is given.|Inflammation biomarkers, hs-C-reactive protein, Baseline, 4 and 12 weeks after each intervention is given.|The hematological parameter for systemic inflammation and stress, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, Baseline, 4 and 12 weeks after each intervention is given.|proinflammtory marker, Glyc-A, Baseline, 4 and 12 weeks after each intervention is given.|Liver function, GOT、GPT, Baseline, 4 and 12 weeks after each intervention is given|Kidney function, BUN、Cre、eGFR(Calculated by age and Cre), Baseline, 4 and 12 weeks after each intervention is given|Evaluation of activity of gut microbiome, TMA、TMAO, Baseline, 4 and 12 weeks after each intervention is given|The concentration of the product of gut microbiome, SCFA (short-chain fatty acid), Baseline, 4 and 12 weeks after each intervention is given|Analysis of Gut Microbiota in Stool Samples Using 16S rRNA Sequencing, 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, 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.|Body fat composition, BMI(calculated y weight and height), Baseline, 4 and 12 weeks after each intervention is given|To evaluate the distribution of body fat, Waist-to-Hip Ratio, Baseline, 4 and 12 weeks after each intervention is given|Effect of intervention on blood pressure control, blood pressure, Baseline, 4 and 12 weeks after each intervention is given|Measurement of overall immune function and response to infection or inflammation, WBC, Baseline, 4 and 12 weeks after each intervention is given|Evaluate the immune system function, CD3、CD4、CD8、CD56, Baseline, 4 and 12 weeks after each intervention is given|Assessment of leukocyte activation, CD11b, Baseline, 4 and 12 weeks after each intervention is given|To evaluates the body's ability to fight tumors and infections., NK cells, Baseline, 4 and 12 weeks after each intervention is given|To assess immune activation and the ability to present antigens to T cells, HLA-DR, Baseline, 4 and 12 weeks after each intervention is given|Assessment of immune response, IFN-gamma、IL-6, Baseline, 4 and 12 weeks after each intervention is given|Marker of inflammation, TNF-alpha, Baseline, 4 and 12 weeks after each intervention is given