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

NCT06522412 | Active Not Recruiting DMC

• 1 other identifier: IRB 113-012-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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?

Conditions

Inflammatory Marker; Gut Microbiome; Trimethylamine N-oxide; HbA1c; Atherosclerosis

Keywords

trimethylamine N-oxide; gut microbiome; cardiovascular disease; atherosclerosis

Outcome Measures

Primary Outcomes (24)

• 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

Study Arms (2)

TL_TH

EXPERIMENTAL

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.

Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETS; Dietary Supplement: JING SI HERBAL TANG HENG POWDER DRINK

TH_TL

ACTIVE COMPARATOR

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.

Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETS; Dietary Supplement: JING SI HERBAL TANG HENG POWDER DRINK

Interventions

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.

TH_TL; TL_TH

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)).

TH_TL; TL_TH

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-75 years.
• Diagnosed with any of the following diseases:
• (1) Hypertension (2) Hyperlipidemia (3) Diabetes (4) Ischemic heart disease"

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 26, 2024
• Study Start: May 1, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)