Rheumatoid arthritis
Conditions
Interventions
Experimental group:Qingli Jiedu Tongluo Formula (Chinese Medicine Granules) +MTX
Control group:Placebo+MTX
Sponsors
Wangjing Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets the 2010 ACR/EULAR RA classification criteria; (2) 5.1>DAS28>3.2 (3) TCM syndrome differentiation is a patient with RA who is consistent with the damp-heat obstruction pattern; (4) duration of illness = 24 months; (5) 18~65 years old; (6) Patient is informed and agrees to participate in this study.
Exclusion criteria
Exclusion criteria: (1) overlapping other rheumatic diseases such as systemic lupus erythematosus ankylosing spondylitis severe osteoporosis recent joint injury and hormone-induced avascular necrosis of the femoral head; (2) Patients with peptic ulcer and history of gastrointestinal bleeding or positive fecal occult blood; (3) Severe cardiovascular and cerebrovascular hepatic renal diseases and malignant tumors; (4) Patients with interstitial lung lesions or recently uncured lung infections; (5) Patients with recent uncured acute liver disease or chronic liver disease or obvious abnormal liver and kidney function (ALT or AST> 1.5 times the upper limit of normal; Cr >upper limit of normal value); (6) Those who have received biological agents and other DMARDS drugs other than methotrexate within 3 months before enrollment; (7) Those who suspect or have a history of alcohol and drug abuse as well as allergies or know to be allergic to the test drug; (8) Women who are preparing to become pregnant pregnant or breastfeeding; (9) Those who are participating in or participating in other clinical trials within 3 months; (10) Other patients who are not considered suitable by the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving remission (DAS28-CRP =2.6) at weeks 6 and 12.;Change in DAS28-CRP from baseline to Weeks 6 and 12;Proportion of subjects achieving low disease activity (DAS28-CRP =3.2) at weeks 6 and 12.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Functional Assessment of Chronic Disease Treatment-Fatigue (FACIT-F) from baseline to weeks 6 and 12;Change from baseline to weeks 6 and 12 as assessed using the Simplified Disease Activity Index (SDAI).;Change in joint Sharp score from baseline to weeks 6 and 12;Change from baseline to weeks 6 and 12 assessed using 100 mm PtAAP-VAS;Change in quality of life (SF36) from baseline to weeks 6 and 12.;Proportion of subjects achieving ACR20/50/70 remission criteria (or response) at weeks 6 and 12;Change from baseline to weeks 6 and 12 as assessed using the Disease Activity Index (CDAI).;Change from baseline to weeks 6 and 12 as assessed using the Global Assessment of Self-Condition (PGA).;Change from baseline to weeks 6 and 12 as assessed using the Physician's Global Assessment of Patient's Condition (MDGA).;Change in HAQ-DI from baseline to weeks 6 and 12.; | — |
Countries
China
Contacts
Public ContactLiu Shenyi
Wangjing Hospital China Academy of Chinese Medical Sciences Chaoyang District Beijing
Outcome results
None listed