The epigenetic characteristtics of cold and heat syndrome of rheumatoid arthritis

Phase 1

• Conditions: rheumatoid arthritis

• Registration Number: ITMCTR2022000078
• Lead Sponsor: Experimental Research Center, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who meet the diagnostic criteria of RA classification published by the American College of Rheumatology (ACR) in 1987 and the ACR/ European League Against Rheumatism (EULAR) in 2010.
(1) Morning stiffness lasts at least 1 hour and lasts for more than 6 weeks;
(2) Swelling of 3 or more joints for at least 6 weeks;
(3) Metacarpedral (toe) joints, proximal interphalangeal (toe) joints are swollen for at least 6 weeks;
(4) Symmetrical joint swelling;
(5) Subcutaneous rheumatoid nodules;
(6) Positive rheumatoid factor (the method used is not more than 5% positive in normal populations);
(7) X-ray photographs of the hands and wrists show bone erosion or clear osteoporosis.
4 or more of the above 7 items can be diagnosed as rheumatoid arthritis.

Diagnostic criteria for RA TCM pattern:
Referring to the Integrative Internal Medicine of Traditional Chinese and Western Medicine published by China Press of Traditional Chinese Medicine Co., Ltd. in 2001 (published in August 2001, pp. 748-749), in which seven common clinical classifications of RA were presented: wind cold dampness resistance, heat evil resistance, phlegm and blood stasis, liver and kidney deficiency, yin deficiency inner heat, kidney-yang deficiency, yin and yang deficiency. Cold pattern and heat pattern are further divided on the basis of the above classification. The wind cold dampness resistance and kidney-yang deficiency are classified as cold pattern. Heat evil resistance and yin deficiency inner heat are classified as heat pattern. And when including patients, the two deputy chief physicians are asked to agree on the diagnosis of cold or heat pattern. In particular, it is not a minority of patients with clinical RA cold-heat complicated pattern, but it is not the scope of our study, and it must be screened and excluded.

Exclusion Criteria

(1) Patients with severe extra-articular manifestations, such as high fever, multiple rheumatoid nodules, interstitial fibrosis of the lungs, renal amyloidosis, constrictive pericarditis, vasculitis, etc. who need to use glucocorticoids;
(2) Patients who have been taking chronic-acting drugs for the treatment of RA for a long time and have not stopped immunosuppressing drugs such as methotrexate, chloroquine, sulfasalazine, cyclophosphamide, penicillamine and gold preparations for at least 1 week before this study;
(3) Patients with serious diseases such as circulation, breathing, digestion, genitourinary, hematopoietic system and central nervous system, and patients with mental illness;
(4) Pregnant or lactating women;
(5) Patients whose past medication record is not clear.
(6) Patients with RA cold-heat complicated pattern.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
m6A;5mC;5hmc;

Secondary Outcome Measures

Name	Time	Method
visual analogue scale (VAS);erythrocyte sedimentation rate (ESR);hemoglobin (Hb);lymphocyte percentage (L%);rheumatoid factor (RF);lymphocyte to monocyte ratio (LMR);IgG;platelet (PLT);IgA;C reactive protein (CRP);IgM;serum albumin (Alb);neutrophil to lymphocyte ratio (NLR);platelet to lymphocyte ratio (PLR);C4;C3;