Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide
Status:
Unknown status
Trial end date:
2018-08-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine