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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186625
Recruitment Status : Unknown
Verified December 2017 by Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : June 14, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Beijing Genomics Institute
Information provided by (Responsible Party):
Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date December 7, 2017
Actual Study Start Date  ICMJE December 5, 2017
Estimated Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • the plasma level of TMAO [ Time Frame: baseline ]
    Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
  • the plasma level of TMAO [ Time Frame: 90-days post-procedure ]
    Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • metagenomic DNA sequencing analysis of faecal microbiome [ Time Frame: baseline ]
    high-throughput sequencing and big data analytics
  • metagenomic DNA sequencing analysis of faecal microbiome [ Time Frame: 90-days post-procedure ]
    high-throughput sequencing and big data analytics
  • 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 )
  • cardiac function [ Time Frame: baseline ]
    left ventricular ejection fraction(LVEF) evaluated by echo
  • cardiac function [ Time Frame: 90-day at follow-up ]
    left ventricular ejection fraction(LVEF) evaluated by echo
  • 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).
  • 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.
  • lipid metabolism [ Time Frame: change from baseline at 90-days ]
    low-density lipoprote in cholesterol in mmol/L
  • lipid metabolism [ Time Frame: change from baseline at 90-days ]
    total cholesterol in cholesterol in mmol/L
  • inflammatory factors [ Time Frame: change from baseline at 90-days ]
    C-reactive protein in mg/L
  • platelet function [ Time Frame: change from Baseline at 90-days ]
    maximal aggregation rate of platelet in percent
  • cardiac biomarkers of necrosis [ Time Frame: Change from Baseline at 5 days ]
    cardiac troponin T (cTnT) in ug/L
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide
Official Title  ICMJE Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • 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.

  • Drug: Placebo Granule
    Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Compound Panax Notoginseng Granule
  • Placebo Comparator: Placebo Granule
    On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.
    Intervention: Drug: Placebo Granule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2018
Estimated Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03186625
Other Study ID Numbers  ICMJE YN2015MS21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Sponsor  ICMJE Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborators  ICMJE Beijing Genomics Institute
Investigators  ICMJE
Study Director: Xiaoyan Li, Master Guangdong Provincial Hospital of Traditional Chinese Medicine
PRS Account Guangdong Provincial Hospital of Traditional Chinese Medicine
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP