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Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide

NCT ID: NCT03186625

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome

Keywords

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acute coronary syndrome gut microbiota Trimethylamine N-oxide percutaneous coronary intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Compound Panax Notoginseng Granule

Intervention Type DRUG

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 Granule

On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.

Group Type PLACEBO_COMPARATOR

Placebo Granule

Intervention Type DRUG

Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.

Interventions

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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.

Intervention Type DRUG

Placebo Granule

Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Genomics Institute

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lei Wang

Associate Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoyan Li, Master

Role: STUDY_DIRECTOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Wang, Ph.D & M.D

Role: CONTACT

Phone: 86-20-81887233-32801

Email: [email protected]

Shuai Mao, M.D

Role: CONTACT

Phone: +8613724078381

Email: [email protected]

Facility Contacts

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Lei Wang, M.D

Role: primary

Other Identifiers

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YN2015MS21

Identifier Type: -

Identifier Source: org_study_id