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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Inflammatory Response; Gut Microbiome; Herbal Medicine; Life Quality; Trimethylamine N-oxide
• Intervention / Treatment: Dietary supplement: Jing Si herbal tea liquid packet

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huai-Ren Chang, M.D. PhD.; Phone Number: 10290 03-8561825; Email: 8311016@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active arm; Jing Si herbal tea liquid packet	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
Placebo Comparator: control arm; Jing Si herbal tea placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
inflammatory biomarkers	GlycA (umol/L)	3 months
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
diabetes control index	HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta	3 months
biomarkers for congestive heart failure	Nt-proBNP (pg/ mL)	3 months
heart function measurement for congestive heart failure	LVEF(%)	3 months
kidney function 1	BUN (mg/dL),Cre (mg/dL)	3 months
kidney function 2	eGFR (mL/min)	3 months
kidney function 3	Urine Albumin to Creatinine Ratio(mg/g)	3 months
Gut microbiome	TMAO (uM)	3 months
immune composition analysis 1	CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)	3 months
immune composition analysis 2	WBC (10^3/uL)	3 months
immune function analysis	IFN-gamma (IU/mL)	3 months

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: microbiome; double-blind randomized controlled trial; Jing Si herbal tea liquid packet; trimethylamine N-oxide (TMAO)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Inflammation
• Other Study ID Numbers: IRB111-025-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no, we are not going to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No