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

5. desember 2017 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510120
        • Rekruttering
        • Guangdong Provincial Hospital of Chinese Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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 komparator: Placebo Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.
Legemiddel: Placebo Granule
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
the plasma level of TMAO
Tidsramme: baseline
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
baseline
the plasma level of TMAO
Tidsramme: 90-days post-procedure
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
90-days post-procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
metagenomic DNA sequencing analysis of faecal microbiome
Tidsramme: baseline
high-throughput sequencing and big data analytics
baseline
metagenomic DNA sequencing analysis of faecal microbiome
Tidsramme: 90-days post-procedure
high-throughput sequencing and big data analytics
90-days post-procedure
major adverse cardiac event
Tidsramme: 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
Tidsramme: baseline
left ventricular ejection fraction(LVEF) evaluated by echo
baseline
cardiac function
Tidsramme: 90-day at follow-up
left ventricular ejection fraction(LVEF) evaluated by echo
90-day at follow-up
Seattle Angina Questionnaire score
Tidsramme: 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
Tidsramme: 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
Tidsramme: change from baseline at 90-days
low-density lipoprote in cholesterol in mmol/L
change from baseline at 90-days
lipid metabolism
Tidsramme: change from baseline at 90-days
total cholesterol in cholesterol in mmol/L
change from baseline at 90-days
inflammatory factors
Tidsramme: change from baseline at 90-days
C-reactive protein in mg/L
change from baseline at 90-days
platelet function
Tidsramme: change from Baseline at 90-days
maximal aggregation rate of platelet in percent
change from Baseline at 90-days
cardiac biomarkers of necrosis
Tidsramme: Change from Baseline at 5 days
cardiac troponin T (cTnT) in ug/L
Change from Baseline at 5 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Samarbeidspartnere

Beijing Genomics Institute

Etterforskere

  • Studieleder: Xiaoyan Li, Master, Guangdong Provincial Hospital of Traditional Chinese Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. desember 2017

Primær fullføring (Forventet)

31. mai 2018

Studiet fullført (Forventet)

31. august 2018

Datoer for studieregistrering

Først innsendt

7. juni 2017

Først innsendt som oppfylte QC-kriteriene

13. juni 2017

Først lagt ut (Faktiske)

14. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. desember 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2017

Sist bekreftet

1. desember 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YN2015MS21

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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