Red Yeast Rice and Subclinical Atherosclerosis in Patient... | NCT02257047

Studies
Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

NCT02257047

Sponsor

Chengdu PLA General Hospital

Status

Unknown status

Last Update Posted

Oct 3, 2017Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Rheumatoid Arthritis

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Oct 2, 2014

First Submission Date that Met QC Criteria

Oct 3, 2014

First Posted Date

Oct 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2017

Last Update Posted Date

Oct 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RYR	Experimental	Patients under the treatment of red yeast rice	Dietary Supplement: RYR
Control	Sham Comparator	Patients under the treatment of tea	Dietary Supplement: Tea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tea	Dietary Supplement		Control
RYR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline in Carotid intima-media thickness at 24 weeks		At 0 week, 12 weeks, 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
aged from 18 to 75 years
without conflict to the written, informed consent signed prior to the enrollment
no severe hepatic or renal disorders
no known carotid artery stenosis
no coagulation disorders
no hypertension

Exclusion Criteria:

being in pregnancy, lactation period or under a pregnancy plan
being allergic to the test drug
not compatible for the trial medication
without full legal capacity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Chengdu Military Area Command PLA		Chengdu	Sichuan	610083	China

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013662	Tea

Ancestor Terms

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages

Browse Leaves

Not provided

Browse Branches

Not provided