Clinical trial NCT05420987: Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease
Official title: The Effects of JING SI HERBAL TEA LIQ UID PACKETS on Inflammation in Patients With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Response
Gut Microbiome
Life Quality
Trimethylamine N-oxide
Cardiovascular Diseases
Herbal Medicine
Keywords: Jing Si herbal tea liquid packet
microbiome
trimethylamine N-oxide (TMAO)
double-blind randomized controlled trial
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: inflammatory biomarkers
timeFrame: 3 months
measure: inflammatory biomarkers
timeFrame: 3 months
measure: lipid profile , Glu-AC, hs_CRP
timeFrame: 3 months
measure: diabetes control index
timeFrame: 3 months
measure: biomarkers for congestive heart failure
timeFrame: 3 months
measure: heart function measurement for congestive heart failure
timeFrame: 3 months
measure: kidney function 1
timeFrame: 3 months
measure: kidney function 2
timeFrame: 3 months
measure: kidney function 3
timeFrame: 3 months
measure: Gut microbiome
timeFrame: 3 months
measure: immune composition analysis 1
timeFrame: 3 months
measure: immune composition analysis 2
timeFrame: 3 months
measure: immune function analysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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