Inflammatory MarkerNCT06522412
The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink
A study testing JING SI HERBAL TEA LIQUID PACKETS and JING SI HERBAL TANG HENG POWDER DRINK in people with Inflammatory Marker and Gut Microbiome, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Through empirical research evaluating the effects of "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" as adjunctive treatments for various cardiovascular diseases, we aim to provide sufficient evidence to address the following questions: 1. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Inflammatory Marker, Gut Microbiome, Trimethylamine N-oxide
- What is being tested?
- JING SI HERBAL TEA LIQUID PACKETS and JING SI HERBAL TANG HENG POWDER DRINK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 20-75 years.
- Diagnosed with any of the following diseases:
- Hypertension (2) Hyperlipidemia (3) Diabetes (4) Ischemic heart disease"
Who cannot join
- History of cancer.
- Subjects with severe or poorly controlled chronic diseases as determined by the principal investigator.
- Poor renal function (eGFR <40 ml/min/1.73m²).
- Pregnant or breastfeeding at the time of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink on Metabolism and Inflammation in Patients With Cardiovascular Diseases
Through empirical research evaluating the effects of "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" as adjunctive treatments for various cardiovascular diseases, we aim to provide sufficient evidence to address the following questions:
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" significantly improve various inflammatory responses involved in the process of atherosclerosis, thereby enhancing the prognosis of patients with acute coronary syndrome and chronic ischemic heart disease?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" provide a healthy and effective adjunctive therapy for patients with hypertension, diabetes, and hyperlipidemia by lowering blood pressure (potentially related to known ACE2 receptors), blood glucose levels (including the improvement of pancreatic β-cell insulin secretion capacity and cellular insulin utilization efficiency), and cholesterol levels?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" influence the prognosis of various diseases, including the most critical cardiovascular conditions such as acute coronary syndrome and chronic ischemic heart disease, by altering the human gut microbiota?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" improve renal indicators such as BUN, creatinine, UACR, and eGFR, thereby protecting the kidneys and reducing complications like microalbuminuria?
Read the detailed description
The Jing-Si Herbal Drink is composed of eight native Taiwanese herbal ingredients: mugwort, fishwort, houttuynia, dwarf lilyturf, balloon flower, perilla leaf, chrysanthemum, and licorice. These ingredients are known for their properties to clear heat, dispel cold, ventilate the lungs, transform phlegm, and eliminate dampness. Preliminary cell and animal studies have demonstrated that this drink can block the binding of the novel coronavirus (SARS-CoV-2) to cells and reduce cellular penetration, thereby preventing the virus from entering the cells. Recently, the Jing-Si Herbal Drink in powder form, known as "Jing-Si Herbal Drink Concentrate Powder," received an export-specific license from the Ministry of Health and Welfare. A research team from Taipei Tzu Chi Hospital has confirmed that combining standard treatment with Jing-Si Herbal Drink provides good clinical protective effects and safety for patients with mild to moderate COVID-19.
Angiotensin-converting enzyme 2 (ACE2), encoded by the ACE2 gene located on the X chromosome, regulates blood pressure and endocrine functions by clearing the vasopressor angiotensin II (Ang II), thereby allowing blood vessels to relax. Studies have shown that the human ACE2 receptor is the gateway for the novel coronavirus (SARS-CoV-2) to enter cells. Both the novel coronavirus and the SARS coronavirus must bind to the ACE2 receptor via their spike proteins to enter cells and replicate extensively, leading to pathogenicity. It is therefore reasonable to hypothesize that the Jing-Si Herbal Drink may block the binding of the novel coronavirus (SARS-CoV-2) to cells by regulating the ACE2 receptor.
Recently, the basic medical research team on herbal drinks at Hualien Tzu Chi Hospital has demonstrated through animal experiments that the Jing-Si Herbal Drink has significant anti-aging protective effects on cardiovascular and metabolic functions in aged rats (24-month-old WKY rats). Additionally, a preliminary analysis conducted by Professor Hong-Chih Han's laboratory at the Hualien Tzu Chi Hospital's Innovation and Research Center revealed that various aspects of immune function were positively affected by the Jing-Si Herbal Drink. It was observed that IFN-γ levels in the blood of subjects significantly increased 48-96 hours after consumption of the Jing-Si Herbal Drink, suggesting that it plays an important role in immune regulation.
The Jing-Si Abode Herbal Research and Development Team has built upon the original Jing-Si Herbal Drink formula to create a new generation of herbal beverage: Jing-Si Herbal Sugar-Balance Beverage. This new formula incorporates pumpkin powder and bitter melon extract powder (containing bitter melon peptides) in addition to the eight original herbal ingredients of the concentrated herbal drink. It is expected to provide enhanced protection for blood sugar and lipid metabolism as well as immune function. Recently, the basic medical research team on herbal drinks at Hualien Tzu Chi Hospital conducted animal experiments that preliminarily confirmed the superior blood sugar-lowering effects of the Jing-Si Herbal Sugar-Balance Beverage formula in diabetic rats compared to the original Jing-Si Herbal Drink formula and the drug Metformin.
The investigators will leverage the professional care provided by clinical physicians and the analytical research capabilities of our basic laboratory to collaboratively evaluate the effects of "Jing-Si Herbal Drink Concentrate" and "Jing-Si Herbal Drink Sugar-Balance Beverage" as adjunctive treatments for patients with various cardiovascular diseases. The investigators aim to not only improve the quality of life for these patients but also achieve beneficial outcomes in treating some clinically challenging diseases and symptoms.
- Being tested
- JING SI HERBAL TEA LIQUID PACKETS, JING SI HERBAL TANG HENG POWDER DRINK
- Keywords
- trimethylamine N-oxide, gut microbiome, cardiovascular disease, atherosclerosis
- Medical subject headings
- Atherosclerosis, 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 PACKETSDietary supplement
JING SI HERBAL TEA LIQUID PACKETS contains: eight herbal ingredients, primarily including dwarf lilyturf, houttuynia, balloon flower, siegesbeckia, licorice, mugwort, perilla leaf, and chrysanthemum. These eight Taiwanese native herbs are known for their abilities to moisturize, disperse cold, relieve lung congestion, dissolve phlegm, remove dampness, and clear heat.
JING SI HERBAL TANG HENG POWDER DRINKDietary supplement
JING SI HERBAL TANG HENG POWDER DRINK contains: Based on the eight herbal ingredients of Jingsi Herbal Drink Concentrate, this drink additionally includes pumpkin powder and bitter melon extract powder. (Ingredients: siegesbeckia, Jingsi complex herbal powder (dextrin fiber, herbal extracts (mugwort, siegesbeckia, dwarf lilyturf, houttuynia, balloon flower, licorice, perilla leaf, chrysanthemum)), pumpkin powder, bitter melon extract powder (bitter melon extract (containing bitter melon peptides), maltodextrin), black pepper, chromium nicotinate complex (chromium nicotinate, sodium chloride)).
| Study group | Role | What they receive |
|---|---|---|
| TL_TH | Experimental | The participants takeJING SI HERBAL TEA LIQUID PACKETS first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TANG HENG POWDER DRINK for 12 weeks. Receives: Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETS; Dietary Supplement: JING SI HERBAL TANG HENG POWDER DRINK |
| TH_TL | Active comparator | The participants take JING SI HERBAL TANG HENG POWDER DRINK first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TEA LIQUID PACKETS for 12 weeks. Receives: Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETS; Dietary Supplement: JING SI HERBAL TANG HENG POWDER DRINK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intervention on lipid profile
TCH、TG、HDL-C、LDL-C
Measured: Baseline, 4 and 12 weeks after intervention is given.
Effect of blood uric acid on Cardiovascular Disease and body inflammation status
Uric acid
Measured: Baseline, 4 and 12 weeks after intervention is given.
Effect of intervention on fasting sugar
Glu-AC
Measured: Baseline, 4 and 12 weeks after intervention is given.
To evaluate the metabolic health
Uric acid
Measured: Baseline, 4 and 12 weeks after intervention is given.
Long term blood sugar status
HbA1C
Measured: Baseline, 4 and 12 weeks after intervention is given.
Homeostatic model assessment (HOMA) of insulin resistance
HOMA-IR is calculated by insulin level and Glu-AC
Measured: Baseline, 4 and 12 weeks after intervention is given.
Inflammation biomarkers
hs-C-reactive protein
Measured: Baseline, 4 and 12 weeks after each intervention is given.
The hematological parameter for systemic inflammation and stress
neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio
Measured: Baseline, 4 and 12 weeks after each intervention is given.
proinflammtory marker
Glyc-A
Measured: Baseline, 4 and 12 weeks after each intervention is given.
Liver function
GOT、GPT
Measured: Baseline, 4 and 12 weeks after each intervention is given
Kidney function
BUN、Cre、eGFR(Calculated by age and Cre)
Measured: Baseline, 4 and 12 weeks after each intervention is given
Evaluation of activity of gut microbiome
TMA、TMAO
Measured: Baseline, 4 and 12 weeks after each intervention is given
The concentration of the product of gut microbiome
SCFA (short-chain fatty acid)
Measured: Baseline, 4 and 12 weeks after each intervention is given
Analysis of Gut Microbiota in Stool Samples Using 16S rRNA Sequencing
This study aims to analyze the gut microbiota in stool samples to assess changes in microbial composition and abundance following the intervention. The primary objective is to determine if the intervention lead to significant shifts in the diversity and relative proportions of gut bacteria
Measured: Stool samples will be collected at baseline (prior to intervention) and at 12 months post-intervention to assess changes in gut microbiota composition and abundance.
Body fat composition
BMI(calculated y weight and height)
Measured: Baseline, 4 and 12 weeks after each intervention is given
To evaluate the distribution of body fat
Waist-to-Hip Ratio
Measured: Baseline, 4 and 12 weeks after each intervention is given
Effect of intervention on blood pressure control
blood pressure
Measured: Baseline, 4 and 12 weeks after each intervention is given
Measurement of overall immune function and response to infection or inflammation
WBC
Measured: Baseline, 4 and 12 weeks after each intervention is given
Evaluate the immune system function
CD3、CD4、CD8、CD56
Measured: Baseline, 4 and 12 weeks after each intervention is given
Assessment of leukocyte activation
CD11b
Measured: Baseline, 4 and 12 weeks after each intervention is given
To evaluates the body's ability to fight tumors and infections.
NK cells
Measured: Baseline, 4 and 12 weeks after each intervention is given
To assess immune activation and the ability to present antigens to T cells
HLA-DR
Measured: Baseline, 4 and 12 weeks after each intervention is given
Assessment of immune response
IFN-gamma、IL-6
Measured: Baseline, 4 and 12 weeks after each intervention is given
Marker of inflammation
TNF-alpha
Measured: Baseline, 4 and 12 weeks after each intervention is given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 May 2024
- Primary completionFeb 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory MarkerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Huai Ren, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522412
- Sponsor's protocol ID
- IRB 113-012-A
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink on Metabolism and Inflammation in Patients With Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT06522412
- Acronym / sponsor ID
- IRB 113-012-A
- Keywords
- trimethylamine N-oxide, gut microbiome, cardiovascular disease, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 2024 (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.
Through empirical research evaluating the effects of "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" as adjunctive treatments for various cardiovascular diseases, we aim to provide sufficient evidence to address the following questions:
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" significantly improve various inflammatory responses involved in the process of atherosclerosis, thereby enhancing the prognosis of patients with acute coronary syndrome and chronic ischemic heart disease?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" provide a healthy and effective adjunctive therapy for patients with hypertension, diabetes, and hyperlipidemia by lowering blood pressure (potentially related to known ACE2 receptors), blood glucose levels (including the improvement of pancreatic β-cell insulin secretion capacity and cellular insulin utilization efficiency), and cholesterol levels?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" influence the prognosis of various diseases, including the most critical cardiovascular conditions such as acute coronary syndrome and chronic ischemic heart disease, by altering the human gut microbiota?
- Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" improve renal indicators such as BUN, creatinine, UACR, and eGFR, thereby protecting the kidneys and reducing complications like microalbuminuria?
Detailed description
The Jing-Si Herbal Drink is composed of eight native Taiwanese herbal ingredients: mugwort, fishwort, houttuynia, dwarf lilyturf, balloon flower, perilla leaf, chrysanthemum, and licorice. These ingredients are known for their properties to clear heat, dispel cold, ventilate the lungs, transform phlegm, and eliminate dampness. Preliminary cell and animal studies have demonstrated that this drink can block the binding of the novel coronavirus (SARS-CoV-2) to cells and reduce cellular penetration, thereby preventing the virus from entering the cells. Recently, the Jing-Si Herbal Drink in powder form, known as "Jing-Si Herbal Drink Concentrate Powder," received an export-specific license from the Ministry of Health and Welfare. A research team from Taipei Tzu Chi Hospital has confirmed that combining standard treatment with Jing-Si Herbal Drink provides good clinical protective effects and safety for patients with mild to moderate COVID-19.
Angiotensin-converting enzyme 2 (ACE2), encoded by the ACE2 gene located on the X chromosome, regulates blood pressure and endocrine functions by clearing the vasopressor angiotensin II (Ang II), thereby allowing blood vessels to relax. Studies have shown that the human ACE2 receptor is the gateway for the novel coronavirus (SARS-CoV-2) to enter cells. Both the novel coronavirus and the SARS coronavirus must bind to the ACE2 receptor via their spike proteins to enter cells and replicate extensively, leading to pathogenicity. It is therefore reasonable to hypothesize that the Jing-Si Herbal Drink may block the binding of the novel coronavirus (SARS-CoV-2) to cells by regulating the ACE2 receptor.
Recently, the basic medical research team on herbal drinks at Hualien Tzu Chi Hospital has demonstrated through animal experiments that the Jing-Si Herbal Drink has significant anti-aging protective effects on cardiovascular and metabolic functions in aged rats (24-month-old WKY rats). Additionally, a preliminary analysis conducted by Professor Hong-Chih Han's laboratory at the Hualien Tzu Chi Hospital's Innovation and Research Center revealed that various aspects of immune function were positively affected by the Jing-Si Herbal Drink. It was observed that IFN-γ levels in the blood of subjects significantly increased 48-96 hours after consumption of the Jing-Si Herbal Drink, suggesting that it plays an important role in immune regulation.
The Jing-Si Abode Herbal Research and Development Team has built upon the original Jing-Si Herbal Drink formula to create a new generation of herbal beverage: Jing-Si Herbal Sugar-Balance Beverage. This new formula incorporates pumpkin powder and bitter melon extract powder (containing bitter melon peptides) in addition to the eight original herbal ingredients of the concentrated herbal drink. It is expected to provide enhanced protection for blood sugar and lipid metabolism as well as immune function. Recently, the basic medical research team on herbal drinks at Hualien Tzu Chi Hospital conducted animal experiments that preliminarily confirmed the superior blood sugar-lowering effects of the Jing-Si Herbal Sugar-Balance Beverage formula in diabetic rats compared to the original Jing-Si Herbal Drink formula and the drug Metformin.
The investigators will leverage the professional care provided by clinical physicians and the analytical research capabilities of our basic laboratory to collaboratively evaluate the effects of "Jing-Si Herbal Drink Concentrate" and "Jing-Si Herbal Drink Sugar-Balance Beverage" as adjunctive treatments for patients with various cardiovascular diseases. The investigators aim to not only improve the quality of life for these patients but also achieve beneficial outcomes in treating some clinically challenging diseases and symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL_TH | Experimental | Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETS, Dietary Supplement: JING SI HERBAL TANG HENG POWDER DRINKThe participants takeJING SI HERBAL TEA LIQUID PACKETS first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TANG HENG POWDER DRINK for 12 weeks. |
| TH_TL | Active comparator | Dietary Supplement: JING SI HERBAL TEA LIQUID PACKETS, Dietary Supplement: JING SI HERBAL TANG HENG POWDER DRINKThe participants take JING SI HERBAL TANG HENG POWDER DRINK first for 12 weeks and then wash-out for 12 weeks, and then take JING SI HERBAL TEA LIQUID PACKETS for 12 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-75 years.
- Diagnosed with any of the following diseases:
- Hypertension (2) Hyperlipidemia (3) Diabetes (4) Ischemic heart disease"
Key exclusion criteria (4 listed)
- History of cancer.
- Subjects with severe or poorly controlled chronic diseases as determined by the principal investigator.
- Poor renal function (eGFR <40 ml/min/1.73m²).
- Pregnant or breastfeeding at the time of screening.
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 PACKETSJING SI HERBAL TEA LIQUID PACKETS contains: eight herbal ingredients, primarily including dwarf lilyturf, houttuynia, balloon flower, siegesbeckia, licorice, mugwort, perilla leaf, and chrysanthemum. These eight Taiwanese native herbs are known for their abilities to moisturize, disperse cold, relieve lung congestion, dissolve phlegm, remove dampness, and clear heat. | Dietary supplement | TH_TL, TL_TH |
| JING SI HERBAL TANG HENG POWDER DRINKJING SI HERBAL TANG HENG POWDER DRINK contains: Based on the eight herbal ingredients of Jingsi Herbal Drink Concentrate, this drink additionally includes pumpkin powder and bitter melon extract powder. (Ingredients: siegesbeckia, Jingsi complex herbal powder (dextrin fiber, herbal extracts (mugwort, siegesbeckia, dwarf lilyturf, houttuynia, balloon flower, licorice, perilla leaf, chrysanthemum)), pumpkin powder, bitter melon extract powder (bitter melon extract (containing bitter melon peptides), maltodextrin), black pepper, chromium nicotinate complex (chromium nicotinate, sodium chloride)). | Dietary supplement | TH_TL, TL_TH |
Primary outcome
Effect of intervention on lipid profile
Time frame: Baseline, 4 and 12 weeks after intervention is given.
TCH、TG、HDL-C、LDL-C
Effect of blood uric acid on Cardiovascular Disease and body inflammation status
Time frame: Baseline, 4 and 12 weeks after intervention is given.
Uric acid
Effect of intervention on fasting sugar
Time frame: Baseline, 4 and 12 weeks after intervention is given.
Glu-AC
To evaluate the metabolic health
Time frame: Baseline, 4 and 12 weeks after intervention is given.
Uric acid
Long term blood sugar status
Time frame: Baseline, 4 and 12 weeks after intervention is given.
HbA1C
Homeostatic model assessment (HOMA) of insulin resistance
Time frame: Baseline, 4 and 12 weeks after intervention is given.
HOMA-IR is calculated by insulin level and Glu-AC
Inflammation biomarkers
Time frame: Baseline, 4 and 12 weeks after each intervention is given.
hs-C-reactive protein
The hematological parameter for systemic inflammation and stress
Time frame: Baseline, 4 and 12 weeks after each intervention is given.
neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio
proinflammtory marker
Time frame: Baseline, 4 and 12 weeks after each intervention is given.
Glyc-A
Liver function
Time frame: Baseline, 4 and 12 weeks after each intervention is given
GOT、GPT
Kidney function
Time frame: Baseline, 4 and 12 weeks after each intervention is given
BUN、Cre、eGFR(Calculated by age and Cre)
Evaluation of activity of gut microbiome
Time frame: Baseline, 4 and 12 weeks after each intervention is given
TMA、TMAO
The concentration of the product of gut microbiome
Time frame: Baseline, 4 and 12 weeks after each intervention is given
SCFA (short-chain fatty acid)
Analysis of Gut Microbiota in Stool Samples Using 16S rRNA Sequencing
Time frame: Stool samples will be collected at baseline (prior to intervention) and at 12 months post-intervention to assess changes in gut microbiota composition and abundance.
This study aims to analyze the gut microbiota in stool samples to assess changes in microbial composition and abundance following the intervention. The primary objective is to determine if the intervention lead to significant shifts in the diversity and relative proportions of gut bacteria
Body fat composition
Time frame: Baseline, 4 and 12 weeks after each intervention is given
BMI(calculated y weight and height)
To evaluate the distribution of body fat
Time frame: Baseline, 4 and 12 weeks after each intervention is given
Waist-to-Hip Ratio
Effect of intervention on blood pressure control
Time frame: Baseline, 4 and 12 weeks after each intervention is given
blood pressure
Measurement of overall immune function and response to infection or inflammation
Time frame: Baseline, 4 and 12 weeks after each intervention is given
WBC
Evaluate the immune system function
Time frame: Baseline, 4 and 12 weeks after each intervention is given
CD3、CD4、CD8、CD56
Assessment of leukocyte activation
Time frame: Baseline, 4 and 12 weeks after each intervention is given
CD11b
To evaluates the body's ability to fight tumors and infections.
Time frame: Baseline, 4 and 12 weeks after each intervention is given
NK cells
To assess immune activation and the ability to present antigens to T cells
Time frame: Baseline, 4 and 12 weeks after each intervention is given
HLA-DR
Assessment of immune response
Time frame: Baseline, 4 and 12 weeks after each intervention is given
IFN-gamma、IL-6
Marker of inflammation
Time frame: Baseline, 4 and 12 weeks after each intervention is given
TNF-alpha
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JING SI HERBAL TEA LIQUID PACKETS and JING SI HERBAL TANG HENG POWDER DRINK in people with Inflammatory Marker and Gut Microbiome, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of intervention on lipid profile (time frame: Baseline, 4 and 12 weeks after intervention is given.). The study lists 24 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 26 Jul 2024.