Inflammatory ResponseNCT05420987
Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease
A study testing Jing Si herbal tea liquid packet in people with Inflammatory Response and Gut Microbiome, run by Buddhist Tzu Chi General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Inflammatory Response, Gut Microbiome, Life Quality
- What is being tested?
- Jing Si herbal tea liquid packet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertension,
- hyperlipidemia,
- ischemic heart disease
- diabetes
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Jing Si herbal tea liquid packet
- Keywords
- Jing Si herbal tea liquid packet, microbiome, trimethylamine N-oxide (TMAO), double-blind randomized controlled trial
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing Si herbal tea liquid packetDietary 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
| Study group | Role | What they receive |
|---|---|---|
| active arm | Experimental | Jing Si herbal tea liquid packet Receives: Dietary Supplement: Jing Si herbal tea liquid packet |
| control arm | Placebo comparator | Jing Si herbal tea placebo Receives: Dietary Supplement: Jing Si herbal tea liquid packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
inflammatory biomarkers
GlycA (umol/L)
Measured: 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)
Measured: 3 months
diabetes control index
HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
Measured: 3 months
biomarkers for congestive heart failure
Nt-proBNP (pg/ mL)
Measured: 3 months
heart function measurement for congestive heart failure
LVEF(%)
Measured: 3 months
kidney function 1
BUN (mg/dL),Cre (mg/dL)
Measured: 3 months
kidney function 2
eGFR (mL/min)
Measured: 3 months
kidney function 3
Urine Albumin to Creatinine Ratio(mg/g)
Measured: 3 months
Gut microbiome
TMAO (uM)
Measured: 3 months
immune composition analysis 1
CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
Measured: 3 months
immune composition analysis 2
WBC (10^3/uL)
Measured: 3 months
immune function analysis
IFN-gamma (IU/mL)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420987
- Sponsor's protocol ID
- IRB111-025-A
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no, we are not going to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of JING SI HERBAL TEA LIQ UID PACKETS on Inflammation in Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05420987
- Acronym / sponsor ID
- IRB111-025-A
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active arm | Experimental | Dietary Supplement: Jing Si herbal tea liquid packetJing Si herbal tea liquid packet |
| control arm | Placebo comparator | Dietary Supplement: Jing Si herbal tea liquid packetJing Si herbal tea placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hypertension,
- hyperlipidemia,
- ischemic heart disease
- diabetes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing Si herbal tea liquid packetJing Si herbal tea includes eight Taiwan native-grown herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice | Dietary supplement | active arm, control arm |
Primary outcome
inflammatory biomarkers
Time frame: 3 months
IL-1b (pg/mL), IL-4(pg/mL), IL-6(pg/mL), IL-10(pg/mL), TNF-gamma(pg/mL),TNF-alpha (pg/mL)
inflammatory biomarkers
Time frame: 3 months
GlycA (umol/L)
lipid profile , Glu-AC, hs_CRP
Time frame: 3 months
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)
diabetes control index
Time frame: 3 months
HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta
biomarkers for congestive heart failure
Time frame: 3 months
Nt-proBNP (pg/ mL)
heart function measurement for congestive heart failure
Time frame: 3 months
LVEF(%)
kidney function 1
Time frame: 3 months
BUN (mg/dL),Cre (mg/dL)
kidney function 2
Time frame: 3 months
eGFR (mL/min)
kidney function 3
Time frame: 3 months
Urine Albumin to Creatinine Ratio(mg/g)
Gut microbiome
Time frame: 3 months
TMAO (uM)
immune composition analysis 1
Time frame: 3 months
CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%)
immune composition analysis 2
Time frame: 3 months
WBC (10^3/uL)
immune function analysis
Time frame: 3 months
IFN-gamma (IU/mL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No. no, we are not going to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Jing Si herbal tea liquid packet in people with Inflammatory Response and Gut Microbiome, run by Buddhist Tzu Chi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huai-Ren Chang, M.D. PhD. (03-8561825 ext. 10290, 8311016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory biomarkers (time frame: 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.