Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03186625
Status:
UNKNOWN
Last Update Posted:
2017-12-07
First Post:
2017-06-07
Brief Title:
Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide
Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Organization:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes A Randomized Placebo Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCM-TMAO
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 syndromeACS undergoing percutaneous coronary intervention 80 patients with ACS would be randomly allocated into interventional groupIG and control groupCG 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 AHAACC guideline for ST-elevation myocardial infarctionSTEMI and Non ST-elevation myocardial infarctionNSTEMIThe 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None