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NCT Number: NCT06522412

The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Marker Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Gut Microbiome HbA1c Trimethylamine N-oxide Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital

Hualien City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-75 years.
  • Diagnosed with any of the following diseases:

(1) Hypertension (2) Hyperlipidemia (3) Diabetes (4) Ischemic heart disease"

Exclusion criteria

  • 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.

Treatment and study plan

JING SI HERBAL TEA LIQUID PACKETS

Dietary Supplement

JING SI HERBAL TEA LIQUID PACKETS contains: eight herbal ingredients, primarily including dwarf lilyturf, houttuynia, balloon flower, siegesbeckia, licorice, mugwort, perilla leaf, and chrysanthemum. These eight Taiwanese native herbs are known for their abilities to moisturize, disperse cold, relieve lung congestion, dissolve phlegm, remove dampness, and clear heat.

JING SI HERBAL TANG HENG POWDER DRINK

Dietary Supplement

JING SI HERBAL TANG HENG POWDER DRINK contains: Based on the eight herbal ingredients of Jingsi Herbal Drink Concentrate, this drink additionally includes pumpkin powder and bitter melon extract powder. (Ingredients: siegesbeckia, Jingsi complex herbal powder (dextrin fiber, herbal extracts (mugwort, siegesbeckia, dwarf lilyturf, houttuynia, balloon flower, licorice, perilla leaf, chrysanthemum)), pumpkin powder, bitter melon extract powder (bitter melon extract (containing bitter melon peptides), maltodextrin), black pepper, chromium nicotinate complex (chromium nicotinate, sodium chloride)).

Primary outcomes

  1. Effect of intervention on lipid profile

    Time frame: Baseline, 4 and 12 weeks after intervention is given.

    TCH、TG、HDL-C、LDL-C

  2. Effect of blood uric acid on Cardiovascular Disease and body inflammation status

    Time frame: Baseline, 4 and 12 weeks after intervention is given.

    Uric acid

  3. Effect of intervention on fasting sugar

    Time frame: Baseline, 4 and 12 weeks after intervention is given.

    Glu-AC

  4. To evaluate the metabolic health

    Time frame: Baseline, 4 and 12 weeks after intervention is given.

    Uric acid

  5. Long term blood sugar status

    Time frame: Baseline, 4 and 12 weeks after intervention is given.

    HbA1C

  6. Homeostatic model assessment (HOMA) of insulin resistance

    Time frame: Baseline, 4 and 12 weeks after intervention is given.

    HOMA-IR is calculated by insulin level and Glu-AC

  7. Inflammation biomarkers

    Time frame: Baseline, 4 and 12 weeks after each intervention is given.

    hs-C-reactive protein

  8. The hematological parameter for systemic inflammation and stress

    Time frame: Baseline, 4 and 12 weeks after each intervention is given.

    neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio

  9. proinflammtory marker

    Time frame: Baseline, 4 and 12 weeks after each intervention is given.

    Glyc-A

  10. Liver function

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    GOT、GPT

  11. Kidney function

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    BUN、Cre、eGFR(Calculated by age and Cre)

  12. Evaluation of activity of gut microbiome

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    TMA、TMAO

  13. The concentration of the product of gut microbiome

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    SCFA (short-chain fatty acid)

  14. Analysis of Gut Microbiota in Stool Samples Using 16S rRNA Sequencing

    Time frame: 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

  15. Body fat composition

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    BMI(calculated y weight and height)

  16. To evaluate the distribution of body fat

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    Waist-to-Hip Ratio

  17. Effect of intervention on blood pressure control

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    blood pressure

  18. Measurement of overall immune function and response to infection or inflammation

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    WBC

  19. Evaluate the immune system function

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    CD3、CD4、CD8、CD56

  20. Assessment of leukocyte activation

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    CD11b

  21. To evaluates the body's ability to fight tumors and infections.

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    NK cells

  22. To assess immune activation and the ability to present antigens to T cells

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    HLA-DR

  23. Assessment of immune response

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    IFN-gamma、IL-6

  24. Marker of inflammation

    Time frame: Baseline, 4 and 12 weeks after each intervention is given

    TNF-alpha

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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