Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Official title:

The Effects of JING SI HERBAL TEA LIQ UID PACKETS on Inflammation in Patients With Cardiovascular Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05420987
• Other study ID #: IRB111-025-A
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: Buddhist Tzu Chi General Hospital
• Contact: Huai-Ren Chang, M.D. PhD.
• Phone: 03-8561825
• Email: 8311016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan.

The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change.

We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting.

The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.

Description:

Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan.

The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change.

We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting.

The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.

All the patients' specimens and questionnaires are going to be collected on Day0, Day28, and Day84.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• hypertension,

• hyperlipidemia,

• ischemic heart disease

• diabetes

Exclusion Criteria:

• cancer patients,

• have comorbidities with poor control

• patients with eGFR< 40 ml/min/1.73m2

• who are pregnant, breastfeeding, and in their menstrual period when recruiting

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Gut Microbiome
• Herbal Medicine
• Inflammation
• Inflammatory Response
• Life Quality
• Trimethylamine N-oxide

Intervention

Dietary Supplement:
• Jing Si herbal tea liquid packet
Jing Si herbal tea includes eight Taiwan native-grown herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory biomarkers	IL-1b (pg/mL), IL-4(pg/mL), IL-6(pg/mL), IL-10(pg/mL), TNF-gamma(pg/mL),TNF-alpha (pg/mL)	3 months
Primary	inflammatory biomarkers	GlycA (umol/L)	3 months
Primary	lipid profile , Glu-AC, hs_CRP	Total cholesterol(mg/dL), TG(mg/dL), HDL-C(mg/dL), LDL-C(mg/dL), uric acid (mg/dL) and Glu-AC (mg/dL),hs_CRP(mg/dL)	3 months
Primary	diabetes control index	HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta	3 months
Primary	biomarkers for congestive heart failure	Nt-proBNP (pg/ mL)	3 months
Primary	heart function measurement for congestive heart failure	LVEF(%)	3 months
Primary	kidney function 1	BUN (mg/dL),Cre (mg/dL)	3 months
Primary	kidney function 2	eGFR (mL/min)	3 months
Primary	kidney function 3	Urine Albumin to Creatinine Ratio(mg/g)	3 months
Primary	Gut microbiome	TMAO (uM)	3 months
Primary	immune composition analysis 1	CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)	3 months
Primary	immune composition analysis 2	WBC (10^3/uL)	3 months
Primary	immune function analysis	IFN-gamma (IU/mL)	3 months