Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide (TCM-TMAO)

December 5, 2017 updated by: Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine

Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial

Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and the sequential action of gut microbiota. Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention. 80 patients with ACS would be randomly allocated into interventional group(IG) and control group(CG). The patients in the IG would be administered by oral Compound pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the placebo twice per day during the same period. All of subjects would be administered with standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid, score of The Seattle Angina, fecal DNA extraction and pyrosequencing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
  2. TCM syndrome: Intermingled Phlegm and Blood Stasis.
  3. Aged 18 to 80 years old.
  4. sign a consent form.

Exclusion Criteria:

  1. Cardiogenic shock.
  2. Serious heart failure (NYHA IV or LVEF < 40%).
  3. With severe valvular heart disease.
  4. Severe hepatic or renal insufficiency, with serum Alanine aminotransferase ( ALT) 3 times higher than normal ceiling or serum creatinine not lower than 265 μmol/L.
  5. With acute cerebrovascular disease or severe mental illness.
  6. With active bleeding or severe hematopoietic system disease.
  7. With malignant tumor or life expectancy in less than three years.
  8. Pregnancy or ready to pregnant women, nursing mothers.
  9. History of taking antibiotics within the past two months.
  10. Participating in other clinical subjects .
  11. Failure to sign a consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Compound Panax Notoginseng Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Compound Panax Notoginseng Granule when they enroll.
Drug: Compound Panax Notoginseng Granule

Dosage form:granule. Composition: Panax notoginseng,Codonopsis pilosula,Salvia miltiorrhiza,Pinellia ternata,Medicated Leaven,Coptis chinensis,Citrus reticulata Blanco,etc.

Frequency:two times a day, one package per time. Duration:three months.
Placebo Comparator: Placebo Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.
Drug: Placebo Granule
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the plasma level of TMAO
Time Frame: baseline
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
baseline
the plasma level of TMAO
Time Frame: 90-days post-procedure
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
90-days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
metagenomic DNA sequencing analysis of faecal microbiome
Time Frame: baseline
high-throughput sequencing and big data analytics
baseline
metagenomic DNA sequencing analysis of faecal microbiome
Time Frame: 90-days post-procedure
high-throughput sequencing and big data analytics
90-days post-procedure
major adverse cardiac event
Time Frame: 90-days post-procedure
frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )
90-days post-procedure
cardiac function
Time Frame: baseline
left ventricular ejection fraction(LVEF) evaluated by echo
baseline
cardiac function
Time Frame: 90-day at follow-up
left ventricular ejection fraction(LVEF) evaluated by echo
90-day at follow-up
Seattle Angina Questionnaire score
Time Frame: 90-days
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).
90-days
The traditional Chinese medicine syndrome scale
Time Frame: change from baseline at 90-days
The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.
change from baseline at 90-days
lipid metabolism
Time Frame: change from baseline at 90-days
low-density lipoprote in cholesterol in mmol/L
change from baseline at 90-days
lipid metabolism
Time Frame: change from baseline at 90-days
total cholesterol in cholesterol in mmol/L
change from baseline at 90-days
inflammatory factors
Time Frame: change from baseline at 90-days
C-reactive protein in mg/L
change from baseline at 90-days
platelet function
Time Frame: change from Baseline at 90-days
maximal aggregation rate of platelet in percent
change from Baseline at 90-days
cardiac biomarkers of necrosis
Time Frame: Change from Baseline at 5 days
cardiac troponin T (cTnT) in ug/L
Change from Baseline at 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Genomics Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xiaoyan Li, Master, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YN2015MS21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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