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

NCT ID: NCT05420987

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-12-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

active arm

Jing Si herbal tea liquid packet

Group Type: EXPERIMENTAL

Jing Si herbal tea liquid packet

Intervention Type: DIETARY_SUPPLEMENT

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

control arm

Jing Si herbal tea placebo

Group Type: PLACEBO_COMPARATOR

Jing Si herbal tea liquid packet

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Huai-Ren Chang, M.D. PhD.

Role: CONTACT

8311016@gmail.com

03-8561825 ext. 10290

Other Identifiers

IRB111-025-A

Identifier Type: -

Identifier Source: org_study_id