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

B

Buddhist Tzu Chi General Hospital

Status

Not yet enrolling

Conditions

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

Treatments

Dietary Supplement: Jing Si herbal tea liquid packet

Study type

Interventional

Funder types

Other

Identifiers

NCT05420987
IRB111-025-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

active arm
Experimental group
Description:
Jing Si herbal tea liquid packet
Treatment:
Dietary Supplement: Jing Si herbal tea liquid packet
control arm
Placebo Comparator group
Description:
Jing Si herbal tea placebo
Treatment:
Dietary Supplement: Jing Si herbal tea liquid packet

Trial contacts and locations

0

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Central trial contact

Huai-Ren Chang, M.D. PhD.

Data sourced from clinicaltrials.gov

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