NCT02408094

Brief Summary

The purpose of this study is to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

March 31, 2015

Last Update Submit

April 22, 2017

Conditions

Keywords

Rheumatoid ArthritisHeat-dampness and blood stasis syndromeProtein markers

Outcome Measures

Primary Outcomes (1)

  • serum and saliva protein markers

    six hours

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rheunmtoid arthritis and "heat-dampness and blood stasis" syndrome

You may qualify if:

  • Subjects are made or confirmed diagnosis according to the American College of Rheumatology criterion and "heat-dampness and blood stasis" syndrome according to Traditional Chinese Medicine.

You may not qualify if:

  • Subjects have other serious diseases, such as liver and kidney disease, cerebral-cardio vascular diseases.
  • Subjects, who belong to "non-heat-dampness and blood stasis" syndrome, have double syndrome of heat or dampness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jiao Juan, Doctor

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiao Juan, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations