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

NCT05420987 | Unknown

• 1 other identifier: IRB111-025-A
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

active arm

EXPERIMENTAL

Jing Si herbal tea liquid packet

Dietary Supplement: Jing Si herbal tea liquid packet

control arm

PLACEBO COMPARATOR

Jing Si herbal tea placebo

Dietary Supplement: Jing Si herbal tea liquid packet

Interventions

Jing Si herbal tea liquid packet 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

active arm; control arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hypertension,
• hyperlipidemia,
• ischemic heart disease
• diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Huai-Ren Chang, M.D. PhD.

CONTACT

03-8561825; 8311016@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 16, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share